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 | VIGOR(TM) DR PACEMAKER SYSTEM |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S006 |
Date Received | 10/16/1996 |
Decision Date | 11/12/1996 |
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 ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT WAS REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL APPLIES ONLY TO THE REQUEST FOR A NEW STERILIZATION FACILITY |
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