|
Device | IMPLANT CONTROL SYSTEM (ICS) 3000 |
Generic Name | implantable pacemaker Pulse-generator |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S035 |
Date Received | 07/28/2003 |
Decision Date | 05/18/2005 |
Product Codes |
DTB DXY KRG |
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 IMPLANT CONTROL SYSTEM (ICS) 3000 PACEMAKER PROGRAMMING SYSTEM, USING SOFTWARE VERSION 402.U. |