PMA P830045S068
- Device
- Trilogy/solus Ii/paragon Iii/phoenix Iii/synchrony Ii,iii/ad
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S068
- Decision date
- 2000-02-18
Current openFDA PMA Record
- Device
- TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P830045
- Supplement
- S068
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 2000-02-18
- Decision code
- OK30
- Date received
- 2000-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-day notice requested the elimination of in-process x-ray imgaing for all bradycardia pulse generators.