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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 NumberS003
Date Received09/11/1995
Decision Date03/21/1996
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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