|
Device | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S162 |
Date Received | 03/24/2016 |
Decision Date | 05/27/2016 |
Product Code |
DXY |
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 programmer software PSW 1506.U/1. |