PMA P820076S019

Device
MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S019
Product code
LWP
Decision date
1996-01-24
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U

Current openFDA PMA Record#

Device
MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U
Applicant
Biotronik, Inc.
PMA number
P820076
Supplement
S019
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
1996-01-24
Decision code
APPR
Date received
1995-05-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U