PMA P820076S017
- Device
- BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S017
- Product code
- LWP
- Decision date
- 1995-09-07
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER
Current openFDA PMA Record#
- Device
- BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S017
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1995-09-07
- Decision code
- APPR
- Date received
- 1994-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SWM 600 VERSION DO5U01 SOFTWARE MODULE FOR USE WITH THE MODEL PMS 600 PROGRAMMER