|
Device | MODEL 0010 BIPOLAR ENDOCARDIAL LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830060 |
Supplement Number | S039 |
Date Received | 05/01/1995 |
Decision Date | 08/28/1995 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO THE MODEL 0010 LEAD AND TO USE A "TRAY-IN-TRAY" PACKAGING SYSTEM FRO THE LEAD |