Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 


New Search Back To Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

Premarket Approval (PMA) Database

Trade NameCONCERTO ICD
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS062
Date Received01/16/2007
Decision Date03/15/2007
Product Code
NIK [ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type real-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Approval Order Statement  Approval for minor design changes to the battery connector module for entrust 35j, concerto, and virtuoso icds.

Database Updated 02/06/2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH