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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVIGOR(TM) DR PACEMAKER SYSTEM
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS007
Date Received11/20/1996
Decision Date01/14/1997
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
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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