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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.
 
DeviceSTRATOS, EVIA, ENTOIVS, ELUNA 8, EPYRA 8, and ETRINSA 8
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP070008
Supplement NumberS097
Date Received08/22/2018
Decision Date10/22/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an updated version of Renamic and ICS 3000 programmer software, PSW 1802.U.
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