PMA P880086S069
- Device
- TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S069
- Product code
- DXY
- Decision date
- 2000-02-18
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- The 30-day notice requested the elimination of in-process x-ray imaging for all bradycardia pulse generators.
Current openFDA PMA Record#
- Device
- TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S069
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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 imaging for all bradycardia pulse generators.