PMA P820018S068
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S068
- Product code
- LWP
- Decision date
- 1995-10-10
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE ADDITION OF A POLYAMIDE INSULATOR TO THE TELEMETRY COIL
Current openFDA PMA Record
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S068
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1995-10-10
- Decision code
- APPR
- Date received
- 1995-08-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A POLYAMIDE INSULATOR TO THE TELEMETRY COIL