PMA P880006S065
- Device
- Sensolog/dialog/regency Pacemakers
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S065
- Decision date
- 2010-02-03
Current openFDA PMA Record
- Device
- SENSOLOG/DIALOG/REGENCY PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S065
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-02-03
- Decision code
- APPR
- Date received
- 2009-10-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE STERILIZATION CYCLE.