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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 DR/SR/DISCOVER/MERIDIAN
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantGUIDANT CORP.
PMA NumberP940031
Supplement NumberS063
Date Received06/03/2008
Decision Date07/02/2008
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of certain electrical testing for capacitors during incoming inspection activities.
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