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. |
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Device | Pulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S090 |
Date Received | 02/09/2018 |
Decision Date | 12/19/2018 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 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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