|
Device | CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S029 |
Date Received | 07/13/2007 |
Decision Date | 12/07/2007 |
Product Code |
LWS |
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 APPLICATION SOFTWARE VERSION A-K00.10U OF THE PMS/TMS 1000, AND APPLICATION SOFTWARE VERSION 703.U/1 OF THE ICS 3000. |