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, LUMOS DR-T, & XELOS DR-T ICDS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S040 |
Date Received | 06/08/2010 |
Decision Date | 11/26/2010 |
Product Code |
MRM |
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 ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS. |
Approval Order | Approval Order |
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