PMA P900066S014

Device: ISPAN Perfluoropropane C3F8 Gas
Applicant: Airgas Therapeutics, LLC
Product code: LPO
Decision date: 2022-08-04
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: Approval to replace the gas chromatograph used to complete in-process quality testing during the distillation of the bulk perfluoropropane gas.

Current openFDA PMA Record#

Device: ISPAN Perfluoropropane C3F8 Gas
Applicant: Airgas Therapeutics, LLC
PMA number: P900066
Supplement: S014
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2022-08-04
Decision code: APPR
Date received: 2021-09-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to replace the gas chromatograph used to complete in-process quality testing during the distillation of the bulk perfluoropropane gas.