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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.
 
DevicePulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP070008
Supplement NumberS090
Date Received02/09/2018
Decision Date12/19/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 3.0 Tesla MR Conditional labeling of Edora, Evity and Enitra ProMRI pacemaker and CRT-P systems.
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