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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(R) DR/SR PACEMAKER SYSTEM
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS009
Date Received12/23/1996
Decision Date02/18/1997
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 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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