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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.
DeviceEvia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP,
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
6024 jean road
lake oswego, OR 97035
PMA NumberP070008
Supplement NumberS091
Date Received02/23/2018
Decision Date06/19/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for changes to the visual inspection of embedded particulate matter within the header matrix of ICDs and pacemakers.