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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 Avenue North
St. Paul, MN 55112
PMA NumberP940031
Supplement NumberS003
Date Received09/11/1995
Decision Date03/21/1996
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE VIGOR MODEL 2880 SOFTWARE APPLICATION USED IN CONJUNCTION WITH THE MODEL 2909 MULTIPLE APPLICATIO UTILITY (MAU) ON THE MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGRO PACEMAKERS
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