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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-D MODELS (N050, N051), ENERGEN CRT-D MODELS (N140, N141) INCEPTA CRT-D MODELS (N160, N161, N164)
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP010012
Supplement NumberS282
Date Received02/09/2012
Decision Date03/15/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes and associated manufacturing changes to the punctua/ incepta/ energen hybrid assembly.
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