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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceETRINSA 8 HF-T, EPYRA 8 HF-T, ELUNA 8 HF-T CRT-P'S
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP070008
Supplement NumberS053
Date Received06/23/2014
Decision Date11/17/2014
Product Code NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ETRINSA, EPYRA AND ELUNA PACEMAKER FAMILIES WITH PROGRAMMER SOFTWARE 1304.U FOR THE RENAMIC PROGRAMMER AND HOME MONITORING SERVICE CENTER WITH SOFTWARE VERSION 3.26.0.
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