|
Device | ENDOTAK RELIANCE FAMILY OF LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S060 |
Date Received | 11/23/2005 |
Decision Date | 12/15/2005 |
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 RETROACTIVE CHANGES MADE TO THE IS-1 (INTERNATIONAL STANDARD LEAD CONNECTOR), DF-1 (DEFIBRILLATOR CONNECTOR) TERMINAL CRIMP, AND DF-1 DISTAL FITTING STAKE FOR ENDOTAK RELIANCE FAMILY OF LEADS. |