|
Device | BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S038 |
Date Received | 11/25/2009 |
Decision Date | 01/22/2010 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SOFTWARE UPGRADE TO VERSION 902.U/1. THIS SOFTWARE IS USED IN THE ICS 3000 SYSTEM TO PROGRAM AND INTERROGATE ALL OF BIOTRONIK¿S US MARKET RELEASED BRADYCARDIA AND TACHYCARDIA PACEMAKERS. |