Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P060006 12/11/08 |
Boston Scientific Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the Boston Scientific Express® SD Renal Monorail® Premounted Stent System. The device is indicated as an adjunct to percutaneous transluminal renal angioplasty (PTRA) of a single de novo or restenotic atherosclerotic lesion (<=15 mm in length) of the renal artery, located within 5 mm of the opacified aortic lumen, with a reference vessel diameter of 4.0 – 7.0 mm to assist in the maintenance of vessel patency. |
| P080007 12/4/08 |
Bard® E·LUMINEXX Vasular Stent | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for the Bard® E·LUMINEXX Vasular Stent. The device is indicated for the treatment f iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 5 to 9 mm. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16837/S006 12/17/08 135-Day |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Approval for the addition of an alternate supplier. |
| P790017/S098 12/24/08 180-Day |
Gruntzig Dilaca Balloon Dilatation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for an alternate sterilization site located at Isotron PLC, Daventry, United Kingdom. |
| P820003/S087 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P840001/S122 12/8/08 Real-Time |
Restore, RestorePRIME, RestoreADVANCED, Restore Prime ADVANCED, and RestoreULTRA Neurostimulation Systems | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of a stabilizing coil to the Model 37083 Extension, a “post-cure” processing step at the distal end of the Models 37083 and 37082 Extensions, and a Proximal Bond Strength (Thermal Bond) design Requirement for Models 37083 and 37082 Extensions. |
| P840064/S036 12/15/08 180-Day |
DUOVISC® Viscoelastic System and DISCOVISC OVD | Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for an alternate sterilization site at Sterigenics Germany GmbH in Germany. |
| P850051/S069 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P860019/S221 12/4/08 135-Day |
PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change in the sampling performed by the supplier for measuring the coating thickness of the hypotube component. |
| P890003/S151 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P890047/S024 12/15/08 180-Day |
PROVISC® Ophthalmic Viscosurgical Device (OVD) | Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for an alternate sterilization site at Sterigenics Germany GmbH in Germany. |
| P900009/S021 12/19/08 180-Day |
Exogen 2000, 3000 Bone Healing System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for labeling modifications aimed to simplify the device labeling. |
| P900061/S079 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P910023/S189 12/18/08 180-Day |
Cadence, Contour, Contour II, Contour MD, Angstrom II, Angstrom MD, Profile II, Profile MD, Photon DR, Photon Micro, Atlas, Atlas+, Atlas II, Atlas II+, Epic, Epic+, Epic II, Epic II+, Convert, Convert+, Current | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, LLC, Arecibo, Puerto Rico. |
| P910023/S195 12/23/08 Real-Time |
Current RF Family of Devices | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for minor design modifications to the header component on all St. Jude Medical Current RF and Promote (Unity) family devices. |
| P910023/S196 12/16/08 Real-Time |
Cadence Tiered-Therapy Defibrillator System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for enhancements to the software (version 3.1) used in the St. Jude Medical Merlin.net system. |
| P910023/S197 12/19/08 Real-Time |
Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the version 3.1 of the Model EX2000 software for the Merlin@home devices. |
| P910066/S025 12/24/08 180-Day |
SpinaLogic, OL1000, and OL1000 Single Coil Bone Growth Stimulators | dj Orthopedics, LLC Vista, CA 92081 |
Approval for upgrades to the OL1000 Single Coil, Size 1 model and the microprocessor-controller (control box) used for the OL1000 Single Coil, Size 1 model. |
| P930016/S031 12/1/08 180-Day |
STAR S4 IR Excimer Laser System | AMO Manufacturing USA, LLC Milpitas, CA 95035 |
Approval for modification of the STAR Patient's Chair. The device, as modified, will he marketed under the trade name STAR S4 IR Excimer Laser System and is indicated for wave front-guided (WFG) laser assisted in situ keratomileusis (LAS1K) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6.00 D MRSE. with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and 4) with a successful preoperative trial of monovision or history of monovision experience. |
| P930022/S008 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P930027/S007 12/30/08 180-Day |
IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000 and IMMULITE® 2500 PSA, 3 rd Generation PSA |
Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Limited, Gwynedd, United Kingdom. |
| P950009/S008 12/3/08 Panel |
BD FocalPoint™ GS Imaging System | BD Diagnostics Durham, NC 27703 |
Approval for the BD FocalPoint™ GS Imaging System. This device is indicated to assist in cervical cancer screening of BD SurePath™ Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma, and their usual precursor conditions. These slides will be ranked according to the likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view (FOVs) most likely to contain abnormal cells. Additionally, the system identifies at least 15% of all successfully processed slides with the BD Focal Point™ Slide Profiler* Directed QC Technology™ for a directed QC re-screen. Intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director. |
| P950032/S049 12/10/08 Real-Time |
Apligraf | Organogenesis, Inc. Canton, MA 02021 |
Approval for a new cell strain, HEP 014, for introduction into production of Apligraf. |
| P960040/S182 12/11/08 Real-Time |
TELIGEN™ Implantable Cardioverter Defibrillator | Boston Scientific CRM St. Paul, MN 55112 |
Approval for the Programmer SW Model 2868 v1.04 and nominal parameters loaded during manufacturing. |
| P960058/S073 12/9/08 Special |
Harmony HiResolution Bionic Ear System | Advanced Bionics, LLC Sylmar, CA 91342 |
Approval for a new repair service for speech processors with associated letters to patients (adult, pediatric) which accompanies the replacement processor. |
| P970003/S100 12/19/08 Real-Time |
VNS Therapy™ PerenniaFLEX™ | Cyberonics, Inc. Houston, TX 77058 |
Approval for the following minor modifications to the approved Model 303 stimulation lead (the new model to be referred to as "304"): 1) Changing the coil material to one with a lower titanium tolerance (< 0.01%) to improve fatigue resistance; 2) Changing the insulating material to one that is similar, but with improved fatigue and abrasion resistance; 3) Adding a controlled fillet to the electrode bifurcation to improve fatigue resistance, and 4) Adding an intermediate electrode size (2.5 mm) that also offers nerve coverage >360 °. |
| P970003/S103 12/19/08 Real-Time |
VNS Therapy™ System | Cyberonics, Inc. Houston, TX 77058 |
Approval for the addition of a software accessory/tool referred to as the “Generator Field Upgrader” (GFU). The GFU is designed to be used to upgrade software in the Demipulse™, Model 103 and Demipulse Duo™, Model 104 Pulse Generators to either enhance pre-existing features or to resolve software anomalies. |
| D970003/S104 12/22/08 Real-Time |
ALTRUA and INSIGNIA Families of Devices | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for changes to the ALTRUA and INSIGNIA families of devices including software changes for the programmer SW Model 2892 v4.01 and labeling changes for the Brady Patient Handbook. |
| P970012/S040 12/24/08 135-Day |
Kappa 400 DR, Kappa 400 SR | Medtronic, Inc. Mounds View, MN 55126 |
Approval for a change in the barb fastener manufacturing process. |
| P970012/S045 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P970029/S013 12/30/08 180-Day |
TMR Holmium Laser System | Cardiogenesis Corp. Irvine, CA 92618 |
Approval of the post-approval study protocol. |
| P980016/S163 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P980022/S037 12/16/08 180-Day |
Continuous Glucose Monitoring System | Medtronic MiniMed, Inc. Northridge, CA 91325 |
Approval for software changes made to the Guardian REAL-Time Glucose Monitor (CSS7100) and Paradigm REAL-Time Insulin Infusion Pump (MMT-522, MMT-522k, MMT-722 and MMT-722k). |
| P980035/S109 12/24/08 135-Day |
Kappa 600/700, 650, 800/900; Sigma; Medtronic 350 Series, EnPulse II; AT501 DDDRP; Adapta/Versa/Senia | Medtronic, Inc. Mounds View, MN 55126 |
Approval for a change in the barb fastener manufacturing process. |
| P980035/S118 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P980049/S029 12/5/08 135-Day |
Ovatio VR 6250 and Ovatio DR 6550 | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for a change in the lot acceptance life test. |
| P980050/S037 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P990001/S041 12/24/08 135-Day |
Dema (Includes Clarity DDDR, clarity SSIR, Diamond II, Ruby III, Topaz III, Jade III, Via II DDDR) | Medtronic, Inc. Mounds View, MN 55126 |
Approval for a change in the barb fastener manufacturing process. |
| P990001/S046 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P990037/S028 12/17/08 Real-Time |
Duett™ Pro Sealing Device, Model 1010 | Vascular Solutions, Inc. Minneapolis, MN 55369 |
Approval to extent the shelf life of the sodium phosphate procoagulant diluent, used only in the Duet™ Pro Sealing Device, Model 1010, from 2 years to 5 years. |
| P000006/S012 12/19/08 Real-Time |
Coloplast Titan® Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55311 |
Approval for three larger cylinder sizes (i.e., lengths of 24, 26, and 28 cm), and related changes for larger packaging, a modification to the cylinder manufacturing process, additional labels for the larger cylinder sizes, revised instructions for use to include additional catalog numbers for the new cylinder sizes, and a new labeling statement that recommends use of the l00cc reservoir with the new larger cylinder sizes. |
| P000007/S014 12/12/08 180-Day |
Edwards Prima Plus Stentless Bioprosthesis, Model 2500P | Edwards Lifesciences Irvine, CA 92614 |
Approval for updated labeling based on the post approval study. |
| P000009/S029 12/24/08 135-Day |
Lumos ICDs with Home Monitoring, Tachos, Below, and Xelos DR-R ICDs | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for changes to the visual inspection criteria for glass feedthroughs used in batteries. |
| P000025/S035 12/19/08 180-Day |
COMBI 40+ Cochlear Implant System | Med-El Corporation Durham, NC 27713 |
Approval for the Maestro system software version 3.0 as external software for use with the MED-EL COMBI 40+ Cochlear Implant System, including removal of the current restriction regarding use of the FSP coding strategy by inexperienced adult users. |
| P000054/S017 12/4/08 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 |
Approval for a change in the specific activity specification range of dibotermin alfa drug substance and drug product. |
| P000058/S028 12/4/08 135-Day |
INFUSE® Bone Graft/LT CAGE Lumbar Tapered Fusion Device | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 |
Approval for a change in the specific activity specification range of dibotermin alfa drug substance and drug product. |
| P010012/S194 12/11/08 Real-Time |
COGNIS™ Cardiac Resynchronization HE Defibrillator | Boston Scientific CRM St. Paul, MN 55112 |
Approval for the Programmer SW Model 2868 v1.04 and nominal parameters loaded during manufacturing. |
| P010015/S050 12/24/08 135-Day |
InSync; InSync III | Medtronic, Inc. Mounds View, MN 55126 |
Approval for a change in the barb fastener manufacturing process. |
| P010015/S055 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P010025/S013 12/22/08 180-Day |
Selenia Dimensions (2D) Full Field Digital Mammography System | Hologic, Inc. Bedford, MA 01730 |
Approval for the Selenia Dimensions (2D) FFDM System. |
| P010031/S130 12/11/08 Real-Time |
All Pulse Generators, ICDs, CRT Pulse Generators, and CRT ICDs approved with the exception of Consulta CRT-D D224TRK, Secura DR D224DRG, Secura VR D224VRC, Maximo II CRT-D D284TRK, Maximo II DR D284DRG, Maximo II VR D284VRC and Model 9995 Application Software |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P010050/S006 12/16/08 180-Day |
IMMULITE/ IMMULITE 1000, IMMULITE 2000 HBsAg and IMMULITE/ IMMULITE 1000 HBsAg Confirmatory | Siemens Healthcare Diagnostics, Inc. E. Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Ltd., Wales, United Kingdom. |
| P010051/S005 12/16/08 180-Day |
IMMULITE/ IMMULITE 1000, IMMULITE 2000 Anti-HBc | Siemens Healthcare Diagnostics, Inc. E. Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Ltd., Wales, United Kingdom. |
| P010052/S005 12/16/08 180-Day |
IMMULITE/ IMMULITE 1000, IMMULITE 2000 Anti-HBs | Siemens Healthcare Diagnostics, Inc. E. Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Ltd., Wales, United Kingdom. |
| P010053/S004 12/16/08 180-Day |
IMMULITE/ IMMULITE 1000, IMMULITE 2000 Anti-HBc IgM | Siemens Healthcare Diagnostics, Inc. E. Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Ltd., Wales, United Kingdom. |
| P020009/S040 12/4/08 135-Day |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change in the sampling performed by the supplier for measuring the coating thickness of the hypotube component. |
| P020036/S012 12/11/08 Special |
SMART™ and SMART™ Control Nitinol Stent Systems | Cordis Corporation Warren, NJ 07059 |
Approval to incorporate an additional precaution into the Instructions for Use to address the potential for stent fractures that may occur with self-expanding stents such as the Cordis SMART Stent Systems. |
| P030009/S028 12/24/08 180-Day |
Driver and MicroDriver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for an alternate sterilization site located at Isotron PLC, Daventry, United Kingdom. |
| P030017/S090 12/9/08 Special |
Precision™ Spinal Cord Stimulation (SCS) System | Boston Scientific Corporation Sylmar, CA 91342 |
Approval for labeling changes on the Introducer Instructions for Use. |
| P030025/S049 12/4/08 135-Day |
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change in the sampling performed by the supplier for measuring the coating thickness of the hypotube component. |
| P030031/S013 12/24/08 180-Day |
NaviStar ThermoCool & Celsius ThermoCool Diagnostic/Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the labeling to incorporate results of the completed postmarket condition of approval study for the atrial flutter indication. |
| P030047/S016 12/24/08 Special |
Precise, Precise Rx and Precise Pro Rx Nitinol Sent Systems | Cordis Corporation Warren, NJ 07059 |
Approval to incorporate an additional precaution into the Instructions for Use to address the potential for stent fractures that may occur with self-expanding stents such as the Cordis Precise Stent Systems. |
| P030054/S104 12/18/08 180-Day |
Atlas II HF, Atlas+ HF, Atlas II+ HF, Epic HF, Epic II HF, Epic+ HF, Epic II+ HF, Promote | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, LLC, Arecibo, Puerto Rico. |
| P030054/S110 12/23/08 Real-Time |
Current RF Family of Devices | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for minor design modifications to the header component on all St. Jude Medical Current RF and Promote (Unity) family devices. |
| P030054/S111 12/19/08 Real-Time |
Epic HF CRT-D System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the version 3.1 of the Model EX2000 software for the Merlin@home devices. |
| P040016/S026 12/4/08 135-Day |
Liberté MR & OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a change in the sampling performed by the supplier for measuring the coating thickness of the hypotube component. |
| P040020/S012 12/22/08 180-Day |
AcrySof® IQ ReSTOR® IOLs +3.0 D | Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for the AcrySof® IQ ReSTOR® Intraocular Lens +3.0 Add power. The device, as modified, will be marketed under the trade name AcrySof© IQ ReSTOR® Intraocular Lens +3.0D (Models SN6AD1 and MN6AD1) and is indicated for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate, and distance vision with increased spectacle independence. This lens is intended to be placed in the capsular bag. |
| P040023/S012 12/30/08 180-Day |
Duraloc Option Ceramic Hip System | DePuy Orthopedics, Inc. Warsaw, IN 46581 |
Approval for a manufacturing site located at CeramTec AG, Marktredwitz, Germany, for manufacturing of the Biolox Forte ceramic heads and liners. |
| P040025/S008 12/24/08 Real-Time |
Olympic Cool-Cap System | Olympic Medical Corporation Seattle, WA 98108 |
Approval for minor hardware and software design changes to the Olympic Cool-Cap System related to a CPU (processor) that has gone end-of-life. |
| P040044/S007 12/14/08 180-Day |
MYNX Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Approval for a manufacturing site located at Nutek Corporation of California, Hayward, California, for E-Beam Sterilization. |
| P040047/S010 12/30/08 135-Day |
Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Approval for an alternate glycerin supplier. |
| P050012/S017 12/3/08 180-Day |
Seven Continuous Glucose Monitoring System (CGMS) | Dexcom, Inc. San Diego, CA 92121 |
Approval for modifications made to the receiver sub-component PCBA and housing; manufacturing processes of the receiver to accommodate a revised PCBA; and outsourcing of the alternative receiver manufacturing process. |
| P050023/S015 12/24/08 135-Day |
Tupos LV/ATx, Kronos LV-T, Lumax 300/340 Family of ICDs and CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for changes to the visual inspection criteria for glass feedthroughs used in batteries. |
| P050023/S016 12/11/08 180-Day |
CardioMessenger II-S and CardioMessenger II-S TLine Home Monitoring Devices for use with Biotronik Implantable Cardioverter Defibrillators |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the CardioMessenger II-S and CardioMessenger II-S TLine Home Monitoring Devices for use with Biotronik Implantable Cardioverter Defibrillators. |
| P050049/S003 12/17/08 Real-Time |
AxSYM® HBsAg, AxSYM® HBsAg Confirmatory and AxSYM® HBsAg Controls | Abbott Laboratories Abbott Park, IL 60064 |
Approval for change of assay files that monitor liquid levels. |
| P050053/S006 12/4/08 135-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 |
Approval for a change in the specific activity specification range of dibotermin alfa drug substance and drug product. |
| P060005/S001 12/30/08 180-Day |
IMMULITE®/ IMMULITE® 1000 and IMMULITE 2000 free PSA | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 |
Approval for a manufacturing site located at Siemens Healthcare Diagnostics Products Limited, Gwynedd, United Kingdom. |
| P060037/S003 12/16/08 135-Day |
NexGen Legacy® Knee – Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee | Zimmer Spine Warsaw, IN 46581 |
Approval for the manufacturing processes utilized during liquid penetrant inspection of components of the device. |
| P060040/S002 12/3/08 Special |
Thoratec HeartMate II® Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for the addition of a caution statement ''WARNING: PRECLOT the graft!" to the package labels for the Outflow Graft with Bend Relief (catalog# 102563) and Inflow Conduit (catalog # 102564). This caution statement is to highlight information currently found in the HeartMate II Instructions for Use, Section 13.4, which instructs users to pre-clot the two components prior to implantation. |
| P070015/S002 12/12/08 180-Day |
XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for an 18-month shelf life. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790018/S050 12/9/08 |
Medtronic Hall Prosthetic Heart Valve | Medtronic, Inc. Minneapolis, MN 55432 |
Use of a new model air sampler. |
| P810046/S227 12/10/08 |
Simpson-Robert Family of Coronary Dilatation Catheters | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the environmental monitoring action limits for viable air and surface testing in the manufacturing production areas. |
| P840064/S039 12/23/08 |
VISCOAT®, DUOVISC®, DISCOVISC® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of electronic batch recording of Buffering/ Compounding, Fill Orders and Sterilization of Reactors/Vessels for the Alcon Ophthalmic Viscosurgical Devices. |
| P860003/S050 12/19/08 |
UVAR XTS Photopheresis System | Therakos, Inc. Exton, PA 19341 |
Transfer of finish product testing from the original manufacturer to the contract manufacturer. |
| P860057/S052 12/17/09 |
Carpentier-Edwards Perimount Pericardial Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Additional supplier for sewing thread twisting. |
| P870056/S031 12/17/08 |
Carpentier-Edwards Bioprosthesis & Bioprosthetic Valved Conduit | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for sewing thread twisting. |
| P870056/S032 12/31/08 |
Carpentier-Edwards Porcine Bioprosthesis and Carpentier-Edwards Bioprosthetic Valved Conduit | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a supplier for porcine tissue. |
| P870077/S030 12/17/08 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for sewing thread twisting. |
| P870077/S031 12/31/08 |
Carpentier Edwards Duraflex Mitral Low Pressure Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a supplier for porcine tissue. |
| P880086/S170 12/4/08 |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Alternate suppliers for various discrete components used on the low voltage and high voltage hybrid assembly of implantable devices. |
| P890003/S153 12/3/08 |
Leads Service & Wrench Kit | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P890003/S156 12/11/08 |
Prodigy SR, Enrhythm IPG Model P150DR | Medtronic, Inc. Mounds View, MI 55112 |
New spray wash equipment and modification of the barb fastener and pin/strap cleaning process. |
| P890003/S158 12/17/08 |
Prodigy IPG | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P890047/S027 12/23/08 |
PROVISC® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of electronic batch recording of Buffering/ Compounding, Fill Orders and Sterilization of Reactors/Vessels for the Alcon Ophthalmic Viscosurgical Devices. |
| P900009/S029 12/18/08 |
Exogen 4000+ Bone Healing System | Smith & Nephew, Inc. Memphis, TN 38116 |
Change in location of the distribution and storage facilities to a facility in Memphis, Tennessee. |
| P900061/S080 12/3/08 |
Epicardial Transvene Lead, Cable Header, Ace Header, Upsizing Sleeve for HV Lead DF-1, Upsizing Sleeve, and End Cap | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P900067/S005 12/9/08 |
ISPAN Sulfur Hexafluoride SF6 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 |
Change of Sulfur Hexafluoride Gas supplier. |
| P910001/S028 12/11/08 |
Angioplasty/Laser/Coronary Device | Spectranetics Corporation Colorado Springs, CO 80907 |
Change to an in-process manufacturing aid. |
| P910023/S193 12/4/08 |
Cadence Family of ICDs | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Alternate suppliers for various discrete components used on the low voltage and high voltage hybrid assembly of implantable devices. |
| P920015/S050 12/3/08 |
Transvenous, Steroid Eluting, Quadripolar, Fixation, Pace/Sense Ventricular Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P930031/S026 12/16/08 |
Wallstent® Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the sterile load configuration and the sterilization load density of the cycle used by the devices. |
| P950024/S013 12/3/08 |
CapSure EPI Epicardial Steroid Eluting Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P950037/S063 12/31/08 |
Cylos Protos, Axios, and Philos Family of Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Change in the component supplier for the battery cathode. |
| P960013/S041 12/31/08 |
Tendril ST Lead | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change to eliminate the plasma priming process. |
| P960028/S031 12/23/08 |
ReZoom Multifocal Acrylic Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sampling plan used for dimensional inspection of three-piece soft acrylic intraocular lenses. |
| P960040/S183 12/18/08 |
Prizm2/Vitality | Guidant Corporation St. Paul, MN 55112 |
Addition of a second supplier for the desiccant material. |
| P960040/S184 12/18/08 |
CONFIENT, TELIGEN & VITALITY Family of Implantable Cardioverter Defibrillators (ICDs) | Guidant Corporation St. Paul, MN 55112 |
Additional component supplier. |
| P960040/S185 12/18/08 |
TELIGEN ICDs | Guidant Corporation St. Paul, MN 55112 |
Additional supplier for low-voltage capacitors. |
| P970008/S041 12/9/08 |
Urologix Targix® System for the treatment of BPH | Urologix, Inc. Minneapolis, MN 55447 |
Minor changes in the manufacturing of the diaphragm seal. |
| P970012/S046 12/11/08 |
Kappa 400 DR, Kappa 400 SR | Medtronic, Inc. Mounds View, MI 55112 |
New spray wash equipment and modification of the barb fastener and pin/strap cleaning process. |
| P970012/S047 12/17/08 |
Kappa 400 DR IPG, Kappa 400 SR IPG | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P970012/S048 12/24/08 |
Kappa 400 DR IPG, Kappa 400 SR IPG | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Change in manufacturing location of the chip resistors. |
| P970020/S053 12/4/08 |
Multi-Link RX Zeta® CSS | Abbott Vascular, Inc. Temecula, CA 92591 |
Addition of an in-process visual inspection step to the catheter manufacturing process. |
| P970020/S054 12/10/08 |
Multi-Link Family of Coronary Stent Systems (CSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the environmental monitoring action limits for viable air and surface testing in the manufacturing production areas. |
| P980016/S167 12/17/08 |
Marquis family of ICDs, Maximo Family of ICDs, Intrinsic Family of ICDs, EnTrust Family of ICDs, Virtuoso II DR, Virtuosi II VR, Onyx ICD, Virtuoso Family of ICDs, Maximo II IPG, Secura ICD | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P980016/S169 12/24/08 |
Marquis DR/VR, Maximo DR/VR, Intrinsic, EnTrust, Virtuoso ICD | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Change in manufacturing location of the chip resistors. |
| P980022/S042 12/16/08 |
Paradigm Real-Time Insulin Pump | Medtronic MiniMed Northridge, CA 91325 |
Change in a vendor supplying a component for the device. |
| P980033/S015 12/16/08 |
Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the sterile load configuration and the sterilization load density of the cycle used by the devices. |
| P980035/S120 12/11/08 |
Kappa 600/700, 650, 800/900; Sigma IPG Family Medtronic 350 Series; EnPulse Family; Adapta, Versa, Sensia Family |
Medtronic, Inc. Mounds View, MI 55112 |
New spray wash equipment and modification of the barb fastener and pin/strap cleaning process. |
| P980035/S122 12/17/08 |
EnPulse Family of IPGs, EnRhythm IPG, Sigma IPG/Medtronic 350 Series, Adapta/Versa/ Sensia Family of IPGs, Relia IPG, AT500 IPG, Kappa 600/700, 650, 800/900 Family of IPGs | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P980035/S123 12/24/08 |
Kappa 600/700, 650 IPG, Kappa 800/900, EnPulse, EnRhythm, Adapta/Versa/ Sensia IPG | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Change in manufacturing location of the chip resistors. |
| P980035/S124 12/24/08 |
Kappa 600/700, 650 IPG; Kappa 800/900 IPG; EnPulse IPG; Adapla/Versa/ Sensia IPG; Relia IPG |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change in the process flow for the manufacturing lean line for the devices. |
| P980040/S026 12/23/08 |
Sensar Soft Acrylic Intraocular Lense | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sampling plan used for dimensional inspection of three-piece soft acrylic intraocular lenses. |
| P980049/S043 12/10/08 |
Isoline 2CR, Isoline 2CT Steroid Eluting Pacing Leads | ELA Medical, Inc. Plymouth, MN 55441 |
Manufacturing site change for the steroid component of the device. |
| P980050/S038 12/3/08 |
SVC/CS Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P990001/S047 12/24/08 |
C-Series, T-Series | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Change in manufacturing location of the chip resistors. |
| P990023/S006 12/23/08 |
CELLUGEL® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of electronic batch recording of Buffering/ Compounding, Fill Orders and Sterilization of Reactors/Vessels for the Alcon Ophthalmic Viscosurgical Devices. |
| P990080/S032 12/23/08 |
Tecnis Acrylic Intraocular Lense | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sampling plan used for dimensional inspection of three-piece soft acrylic intraocular lenses. |
| P000006/S013 12/22/08 |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Use of a new method for marking the Saline Filled Testicular Prosthesis and the Titan Inflatable Penile Prosthesis and for boring suture holes on the Titan Inflatable Penile Prosthesis. |
| P000007/S019 12/17/08 |
Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for sewing thread twisting. |
| P000007/S020 12/31/08 |
Edwards® Prima Plus Stentless Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a supplier for porcine tissue. |
| P000012/S018 12/4/08 |
Roche Molecular Systems COBAS AmpliPrep/COBAS AMPLICOR HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides used in the COBAS AmpliPrep/COBAS AMPLICOR HCV Test with the activator, 4,5 Dicyanoimidazole (DCI). |
| P000012/S019 12/22/08 |
COBAS AmpliPrep/COBAS AMPLICOR HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of redundant functional testing for the final bulk materials prior to filling. |
| P000029/S052 12/12/08 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Backup supplier to include new in-house quality control testing for a raw material used in the Deflux® Injectable Gel manufacturing process. |
| P000036/S006 12/3/08 |
Dermagraft®, Human Fibroblast-Derived Dermal Substitute | Advanced BioHealing La Jolla, CA 92037 |
Changes to an acceptance test method for Dermagraft®. |
| P010012/S195 12/18/08 |
Contact Renewal | Guidant Corporation St. Paul, MN 55112 |
Addition of a second supplier for the desiccant material. |
| P010012/S196 12/18/08 |
RENEWAL 3, LIVIAN & COGNIS Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | Guidant Corporation St. Paul, MN 55112 |
Additional component supplier. |
| P010012/S197 12/18/08 |
COGNIS CRT-Ds | Guidant Corporation St. Paul, MN 55112 |
Additional supplier for low-voltage capacitors. |
| P010012/S198 12/22/08 |
Contak Renewal RF Defibrillator | Guidant Corporation St. Paul, MN 55112 |
Addition of a component supplier for the inductors. |
| P010015/S056 12/3/08 |
Attain OTW/Bipolar OTW/CS | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P010015/S057 12/17/08 |
InSync III CRT-P, InSync CRT-P | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P010031/S134 12/17/08 |
InSync Marquis Family of ICDs, InSync II Protect ICD, InSync CRT-D, InSync II Protect ICD, InSync Sentry Family of ICDs, InSync Maximo Family of ICDs, Concerto CRT-D, Maximo II CRT-D, Consulta CRT-D, Concerto II CRT-D | Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Reduction in the sampling frequency of routine environmental monitoring in the Controlled Environment Are at Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico. |
| P010031/S136 12/24/08 |
InSync Sentry, InSync Maximo CRT-D, InSync II Protect, InSync II Marquis, Concerto ICD |
Medtronic, Inc. Cardiac Rhythm Disease management Mounds View, MN 55112 |
Change in manufacturing location of the chip resistors. |
| P010041/S018 12/17/08 |
Carpentier-Edwards Supraannual (S.A.V.) Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for sewing thread twisting. |
| P010041/S019 12/31/08 |
Carpentier-Edwards S.A.V. Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a supplier for porcine tissue. |
| P020003/S006 12/22/08 |
Saline Filled Testicular Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Use of a new method for marking the Saline Filled Testicular Prosthesis and the Titan Inflatable Penile Prosthesis and for boring suture holes on the Titan Inflatable Penile Prosthesis. |
| P020018/S030 12/19/08 |
Zenith Flex® AAA Endovascular Graft & Zenith® Renu™ AAA Ancillary Graft | Cook Medical, Inc. Bloomington, IN 47402 |
Addition of a contract manufacturer in the construction of subassembly components. |
| P020026/S058 12/8/08 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Change in the lot release sampling plan for the measurement of stent retention force. |
| P020047/S013 12/4/08 |
Multi-Link Vision® RX Family of Coronary Stent Systems (CSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Addition of an in-process visual inspection step to the catheter manufacturing process. |
| P020047/S014 12/10/08 |
Multi-Link Vision® Family of Coronary Stent Systems (CSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the environmental monitoring action limits for viable air and surface testing in the manufacturing production areas. |
| P030006/S020 12/9/08 |
Prolieve Thermodilitation® System | Boston Scientific Corporation Marlborough, MA 01752 |
Addition of an adhesive in the manufacturing of the Rectal Temperature Monitor. |
| P030009/S029 12/15/08 |
Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Removal of duplicate inspection at completion of an in-process work step. |
| P030009/S030 12/31/08 |
Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Change of marker band manufacturing specifications. |
| P030022/S011 12/18/08 |
Reflection Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Change in location of the distribution and storage facilities to a facility in Memphis, Tennessee. |
| P030025/S061 12/16/08 |
TAXUS® Express2™ and TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary stent System (Monorail® and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for finished device packaging. |
| P030035/S049 12/4/08 |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Alternate suppliers for various discrete components used on the low voltage and high voltage hybrid assembly of implantable devices. |
| P030036/S010 12/3/08 |
Lead Assembly | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P030039/S012 12/4/08 |
Coseal Surgical Sealant | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Reconfiguration of the existing approved Hayward facility to include a new manufacturing area. |
| P030054/S108 12/4/08 |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Alternate suppliers for various discrete components used on the low voltage and high voltage hybrid assembly of implantable devices. |
| P040012/S028 12/10/08 |
Acculink® Carotid Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the environmental monitoring action limits for viable air and surface testing in the manufacturing production areas. |
| P040014/S009 12/10/08 |
Therapy Cardiac Ablation Catheters | St. Jude Medical, Inc. Irvine, CA 92614 |
Addition of an alternative tube fusing process. |
| P040023/S013 12/19/08 |
Duraloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Change in the masking process of the grit blasting operation. |
| P040024/S030 12/23/08 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Replacement of a sensor on the assembly line. |
| P040024/S031 12/23/08 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Replacement of a semi-quantitative test method with a quantitative test method. |
| P040033/S009 12/18/08 |
Birmingham Hip Resurfacing System | Smith & Nephew, Inc. Memphis, TN 38116 |
Change in location of the distribution and storage facilities to a facility in Memphis, Tennessee. |
| P040042/S014 12/10/08 |
Therapy Dual 8 Ablation Catheters | St. Jude Medical, Inc. Irvine, CA 92614 |
Addition of an alternative tube fusing process. |
| P040043/S026 12/19/08 |
GORE® TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Change in the method of cooling the endoprosthesis. |
| P050028/S003 12/22/08 |
COBAS TaqMan HBV Test for Use With The High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of redundant functional testing for the final bulk materials prior to filling. |
| P050037/S015 12/5/08 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Alternate oven for the loss on drying final testing of the device. |
| P050052/S016 12/5/08 |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Alternate oven for the loss on drying final testing of the device. |
| P060008/S007 12/16/08 |
TAXUS™ Liberté® Paclitaxel-Eluting Coronary stent System (Monorail® and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate method for finished device packaging. |
| P060019/S007 12/10/08 |
Therapy Cool Path Ablation Catheters | St. Jude Medical, Inc. Irvine, CA 92614 |
Addition of an alternative tube fusing process. |
| P060030/S001 12/4/08 |
Roche Molecular Systems COBAS AmpliPrep/COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides used in the COBAS AmpliPrep/COBAS TaqMan HCV Test with the activator, 4,5 Dicyanoimidazole (DCI). |
| P060030/S002 12/22/08 |
COBAS AmpliPrep/COBAS TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of redundant functional testing for the final bulk materials prior to filling. |
| P060033/S020 12/4/08 |
Endeavor Sprint Zotarolimus-Eluting Rapid Exchange (RX) Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Alternative manufacturing site, Medtronic Mexico, for a subassembly component of the finished device. |
| P060033/S022 12/11/08 |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Additional automation in the stent segment loading process. |
| P060033/S025 12/16/08 |
Endeavor Zotarolimus-Eluting Coronary Stent System and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Equipment modification to the spray machine used to apply the drug coating layer to the devices. |
| P060039/S004 12/3/08 |
Attain Starfix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new model air sampler. |
| P070008/S006 12/31/08 |
Stratos Family of Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Change in the component supplier for the battery cathode. |
| P070015/S007 12/4/08 |
Xience V™ TX Everolimus Eluting CSS | Abbott Vascular, Inc. Temecula, CA 92591 |
Addition of an in-process visual inspection step to the catheter manufacturing process. |
| P070015/S008 12/15/08 |
XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Additional process control step for the pre-sterile packaging process. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 77
Summary of PMA Originals Under Review
Total Under Review: 68
Total Active: 30
Total On Hold: 38
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 505
Total Active: 322
Total On Hold: 183
Number Greater Than 180 Days: 22
Summary of All PMA Submissions Received
Originals: 4
Supplements: 154
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 77
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 132.5
FDA Time: 88.2 Days MFR Time: 44.3 Days
Updated January 29, 2009
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