PMA P900067S006

Device: ISPAN SULFUR HEXAFLUORIDE SF6 GAS
Applicant: Airgas Therapeutics, LLC
PMA number: P900067
Supplement: S006
Product code: LPO
Decision date: 2010-01-13
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 HEXAFLUORIDE SF6 GAS.

Current openFDA PMA Record#

Device: ISPAN SULFUR HEXAFLUORIDE SF6 GAS
Applicant: Airgas Therapeutics, LLC
PMA number: P900067
Supplement: S006
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 HEXAFLUORIDE SF6 GAS.