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 | S007 |
Date Received | 11/20/1996 |
Decision Date | 01/14/1997 |
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 APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE MARCH 20, 1996 "DEAR PRESIDENT OR CEO" LETTER REGARDING CHANGES IN MANUFACTURING SITES. |
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