|
Device | RELIANCE 4-SITE DEFIBRILLATOR LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S107 |
Date Received | 09/28/2012 |
Decision Date | 12/20/2012 |
Product Codes |
LWS NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR DRUG MATERIAL AND SUPPLIER CHANGES AS WELL AS DISTAL TIP DESIGN CHANGES. |
Approval Order | Approval Order |