|
Device | RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S057 |
Date Received | 10/24/2005 |
Decision Date | 11/22/2005 |
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 SIGHT HOLES TO THE TERMINAL PINS, WITH INCREASE IN INSERTION CAVITY FOR THE PASSIVE FIX VERSION, RESULTING IN AN ADDITIONAL INSPECTION STEP. |