PMA P820076S014
- Device
- GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S014
- Product code
- LWP
- Decision date
- 1993-02-09
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S014
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1993-02-09
- Decision code
- APPR
- Date received
- 1991-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material