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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
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP940031
Supplement NumberS001
Date Received06/26/1995
Decision Date02/20/1996
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacing the current connector top material for the above pulse generator models, pellethane 2363-75d polyurethane, with tecothane tt1075d-m polyurethane.
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