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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 NameEVIA HF,EVIA HF-T, ENTOVIS HF, ENTOVIS HF-T
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS035
Date Received11/20/2012
Decision Date02/12/2013
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three separate modifications to the batteries used in the pulse generators.
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