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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVIGOR(TM) DR PACEMAKER SYSTEM
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940031
Supplement NumberS006
Date Received10/16/1996
Decision Date11/12/1996
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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