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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 NameSTRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS038
Date Received01/22/2013
Decision Date02/19/2013
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Reclassifying the environmental conditions from class d to iso 8 cleanrooms.
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