|
Device | IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S034 |
Date Received | 08/21/2000 |
Decision Date | 09/25/2000 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO. |