PMA P900066S013
- Device
- ISPAN PERFLUOROPROPANE C3F8 GAS
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S013
- Product code
- LPO
- Decision date
- 2021-09-28
- Generic name
- Gases used within eye to place pressure on detached retina
- Approval order statement
- Use an additional supplier for toxicity testing as a product release test for perfluoropropane.
Current openFDA PMA Record#
- Device
- ISPAN PERFLUOROPROPANE C3F8 GAS
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S013
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2021-09-28
- Decision code
- OK30
- Date received
- 2021-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an additional supplier for toxicity testing as a product release test for perfluoropropane.