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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 NamePUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-D,ORIGEN CRT-DS,DYNAGEN CRT-D
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP010012
Supplement NumberS353
Date Received05/02/2014
Decision Date05/28/2014
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use an alternate inspection method and equipment with a corresponding specification change.
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