|
Device | RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940008 |
Supplement Number | S002 |
Date Received | 02/05/1996 |
Decision Date | 08/20/1996 |
Withdrawal Date
|
07/20/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SUPPLEMENT WHICH SATISFIES THE REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS. THE POST APPROVAL STUDY WAS REQUIRED AS A CONIDTIN OF APPROVAL IN OUR LETTER DATED NOVEMBER 7, 1995 |