PMA P820018S064
- Device
- Reflex Model 8223e
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S064
- Decision date
- 1994-08-30
Current openFDA PMA Record
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S064
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1994-08-30
- Decision code
- APPR
- Date received
- 1994-07-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename