PMA P900066S015
- Device
- ISPAN Perfluoropropane C3F8 Gas
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S015
- Product code
- LPO
- Decision date
- 2022-02-02
- Generic name
- Gases used within eye to place pressure on detached retina
- Approval order statement
- Change to the firms manufacturing procedure and method of manufacturing.
Current openFDA PMA Record#
- Device
- ISPAN Perfluoropropane C3F8 Gas
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S015
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2022-02-02
- Decision code
- OK30
- Date received
- 2022-01-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the firms manufacturing procedure and method of manufacturing.