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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 PACEMAKER SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual-chamber adaptive-rate pacemaker
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP940031
Supplement NumberS069
Date Received08/23/2010
Decision Date09/14/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the model 3120 programmer system software model 2909 from version 6. 01 to version 7. 01.
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