|
Device | VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S040 |
Date Received | 07/16/2003 |
Decision Date | 12/17/2003 |
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 LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA. |