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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(R) DR/SR PACEMAKER SYSTEM
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP940031
Supplement NumberS009
Date Received12/23/1996
Decision Date02/18/1997
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FORT HE MODIFICATION OF THE DIAGNOSTIC (SELF-TEST) FUNCTION OF THE MDOEL 2909 MULTIPLE APPLICATION UTILITY (MAU) TO ACCOMMODATE VARIABILITY IN WATCH DOG TIMER (WDT) TIME-OUT PERIODS.
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