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 | BELOS & LEXOS DR/DR-T/VR/VR-T ICD'S, LUMOS DR-T/VR-T, XELOS DR-T ICD'S |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S058 |
Date Received | 06/23/2014 |
Decision Date | 11/17/2014 |
Product Codes |
LWS NIK NKE NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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