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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 NameCOGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP010012
Supplement NumberS342
Date Received10/29/2013
Decision Date11/26/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the above referenced devices to the appropriate work instructions.
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