PMA P900066S009

Device: ISPAN PERFLUOROPROPANE C3F8 GAS
Applicant: Airgas Therapeutics, LLC
PMA number: P900066
Supplement: S009
Product code: LPO
Decision date: 2010-01-13
Classification: Gases Used Within Eye To Place Pressure On Detached Retina
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE CLARIFICATION OF THE GAS PRESSURE RESTRICTION LISTED ON THE GAS CYLINDER LABEL AND ENHANCED INSTRUCTION FOR FILLING A SYRINGE WITH ISPAN PERFLUOROPROPANE C3F8 GAS.

Current openFDA PMA Record#

Device: ISPAN PERFLUOROPROPANE C3F8 GAS
Applicant: Airgas Therapeutics, LLC
PMA number: P900066
Supplement: S009
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2010-01-13
Decision code: APPR
Date received: 2009-08-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE CLARIFICATION OF THE GAS PRESSURE RESTRICTION LISTED ON THE GAS CYLINDER LABEL AND ENHANCED INSTRUCTION FOR FILLING A SYRINGE WITH ISPAN PERFLUOROPROPANE C3F8 GAS.