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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 NameCONTAK RENEWAL TR, CONTAK RENEWAL 3, LEVIAN SE/HE, COGNIS, INCEPTA
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP010012
Supplement NumberS280
Date Received01/30/2012
Decision Date02/16/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a shelf life extension from 4 years to 5 years for the subject lv-1 lead port plug.
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