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Device | ACTROS+ FAMILY OF PULSE GENERATORS |
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 | S008 |
Date Received | 03/01/1999 |
Decision Date | 08/24/1999 |
Product Code |
DXY |
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 1) Non-Invasive Programmed Stimulation (NIPS) feature to be unlocked; 2) Automatic Sensor Gain (ASG) feature to be allowed in Actros+ family; 3) Release of programmer software version B-H02.0.U; 4) Change of trade name of PMS 1000C programmer to EPR 1000PLUS; and 5) Use of the B-H02.0.U PCMIA software cartridge with TMS1000 Tachyarrhythmia Monitoring System (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS. |