|
Device | RELIANCE IS -1 AND RELIANCE IS-4 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S090 |
Date Received | 11/16/2010 |
Decision Date | 12/15/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A NEW ACCEPTANCE ACTIVITY FOR A RELIANCE IS-1 AND RELIANCE IS-4 LEAD COMPONENT. |