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 | LUMAX 300/340 VR-T/DR-T/HF-T/LUMAX 500/540 VR-T/DR-T/HF-T/LUMAX 540 VR-T DX |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S046 |
Date Received | 08/19/2011 |
Decision Date | 09/30/2011 |
Product Codes |
LWS MRM 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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE RENAMIC PROGRAMMER AND SOFTWARE VERSION PSW 1101.U. |
Approval Order | Approval Order |
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