Brand Name | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS |
Type of Device | REPLACEMENT HEART VALVE |
Baseline Brand Name | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS |
Baseline Generic Name | NA |
Baseline Catalogue Number | NA |
Baseline Model Number | 2800 |
Baseline Device Family | PERCARDIAL BIOPROSTHESIS |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | P860057 |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 48 |
Date First Marketed | 01/04/1996 |
Manufacturer (Section F) |
EDWARDS LIFESCIENCES |
one edwards way |
irvine CA 92614 |
|
Manufacturer (Section D) |
EDWARDS LIFESCIENCES |
one edwards way |
irvine CA 92614 |
|
Manufacturer Contact |
allison
mezzanatto
|
one edwards way |
irvine
, CA 92614 |
(949)
250
-2562
|
|
Device Event Key | 316368 |
MDR Report Key | 326961 |
Event Key | 307697 |
Report Number | 6000002-2001-00127 |
Device Sequence Number | 1 |
Product Code | LWR |
Report Source |
Manufacturer
|
Source Type |
Study,Health Professional,User facility
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/13/2001 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/12/2001 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 01/01/2003 |
Device MODEL Number | 2800 |
Device LOT Number | 9A0019 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Device Age | 2 yr |
Event Location |
Hospital
|
Date Manufacturer Received | 03/13/2001 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 01/01/1999 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 04/12/2001 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1 |
IMPLANT OF CARPENTIER-EDWARDS PERIMOUNT |
01/01/2001 |
2,PERICARDIAL BIOPROSTHESIS, MODEL 6900 IN THE,01/01/2001 |
3,MITRAL POSITION, 2001.,01/01/2001 |
|
|
|