Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940008 |
Supplement Number | S003 |
Date Received | 02/20/1996 |
Decision Date | 08/22/1996 |
Withdrawal Date
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07/20/2012 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CONSIDER THE INFORMATION PROVIDED IN THIS SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995. THE CONDITION REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED |
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