PMA P820018S065
- Device
- Reflex Model 8223e
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S065
- Decision date
- 1996-07-23
Current openFDA PMA Record
- Device
- REFLEX MODEL 8223E
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P820018
- Supplement
- S065
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-07-23
- Decision code
- APPR
- Date received
- 1994-07-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN STERILIZATION CONTRACTOR. THE PROPOSED STERILIZATION CONTRACTOR IS: GRIFFITH MICRO SCIENCE, INC. 2973 OLYMPIC INDUSTRIAL DRIVE, SMYRNA, GEORGIA 30080-7322