PMA P820018S066
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S066
- Product code
- LWP
- Decision date
- 1996-07-11
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING
Current openFDA PMA Record
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S066
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-07-11
- Decision code
- APPR
- Date received
- 1995-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE USE OF WILSON GREATBATCH BATTERIES WHICH HAVE UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING