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 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S046 |
Date Received | 09/11/2006 |
Decision Date | 12/07/2006 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS), MODELS 300 VR, 340 VR, 300 VR-T, 340 VR-T, 300 DR, 340 DR, 300 DR-T, 340 DR-T, 300 HF, 340 HF, 300 HF-T AND 340 HF-T AND PROGRAMMER SOFTWARE VERSION 603.U FOR USE WITH THE LUMAX FAMILY OF ICDS AND BIOTRONIK, INC. PACERS, SINGLE CHAMBER ICDS AND DUAL CHAMBER ICDS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUMAX, AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND/OR FOR PROVIDING TREATMENT OF CONGESTIVE HEART FAILURE. |
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