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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/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantBIOTRONIK, INC.
PMA NumberP070008
Supplement NumberS057
Date Received09/25/2014
Decision Date03/19/2015
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of the scan location restrictions for the promri pacemaker system as well as updates to the ics 3000/ renamic programmer software (1403. U) for the devices.
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