PMA P820076S016
- Device
- GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S016
- Product code
- LWP
- Decision date
- 1994-09-19
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S016
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1994-09-19
- Decision code
- APPR
- Date received
- 1993-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material