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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,INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P)
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP030005
Supplement NumberS099
Date Received05/22/2013
Decision Date07/25/2013
Product Code
NKE[ Registered Establishments with NKE ]
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 model 2869 zoomview programmer software application v1. 09 and ingenio firmware version d_v1. 02 with patch v1. 01 for the devices.
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