PMA P900067S003

Device: SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
Applicant: Airgas Therapeutics, LLC
PMA number: P900067
Supplement: S003
Product code: LPO
Decision date: 2002-01-29
Generic name: Gases used within eye to place pressure on detached retina
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.

Current openFDA PMA Record#

Device: SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
Applicant: Airgas Therapeutics, LLC
PMA number: P900067
Supplement: S003
Product code: LPO
Generic name: Gases used within eye to place pressure on detached retina
Decision date: 2002-01-29
Decision code: APPR
Date received: 2001-12-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS TO IMPROVE THE PATIENT'S AND DOCTOR'S KNOWLEDGE REGARDING THE HAZARDS OF USING NITROUS OXIDE FOR A SUBSEQUENT SURGICAL PROCEDURE WHEN GAS IS STILL PRESENT IN THE EYE.