PMA P820076S022

Device: GEMNOS & DROMOS SL PULSE GENERATORS
Applicant: Biotronik, Inc.
PMA number: P820076
Supplement: S022
Product code: LWP
Decision date: 1999-08-24
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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 the TMS1000 Tachyarrhythmia Monitoring system (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.

Current openFDA PMA Record#

Device: GEMNOS & DROMOS SL PULSE GENERATORS
Applicant: Biotronik, Inc.
PMA number: P820076
Supplement: S022
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 1999-08-24
Decision code: APPR
Date received: 1999-08-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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 the TMS1000 Tachyarrhythmia Monitoring system (P980023) as well as use of the B-H02.0.U PCMIA software cartridge in the EPR 1000PLUS.