|
Device | ACTROS DR+ -B PULSE GENERATOR |
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 | S009 |
Date Received | 05/14/1999 |
Decision Date | 06/07/1999 |
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 the B-H00.O.U Software module for use with the Biotronik PMS1000 series programmers, and the Actros DR+-B with dual 6mm header ports. |