PMA P900066S017

Device: ISPAN Perfluoropropane C3F8 Gas
Applicant: Airgas Therapeutics, LLC
PMA number: P900066
Supplement: S017
Product code: LPO
Decision date: 2026-04-30
Classification: Ophthalmic
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval to institute Agilent 8890 gas chromatograph and Metrohm 930 ion chromatograph as redundant instruments for the final product release testing.

Current openFDA PMA Record#

Device: ISPAN Perfluoropropane C3F8 Gas
Applicant: Airgas Therapeutics, LLC
PMA number: P900066
Supplement: S017
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2026-04-30
Decision code: OK30
Date received: 2026-04-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to institute Agilent 8890 gas chromatograph and Metrohm 930 ion chromatograph as redundant instruments for the final product release testing.