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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 NameINVIVE V172, V173
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantBOSTON SCIENTIFIC CRV
PMA NumberP030005
Supplement NumberS079
Date Received07/12/2011
Decision Date05/01/2012
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for invive models v172, v173 programmer 2869 application software version 1. 07.
Approval Order Approval Order
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