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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
Generic NameGases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAirgas Therapeutics LLC
6141 Easton Road
Plumsteadville, PA 18949
PMA NumberP900067
Supplement NumberS003
Date Received12/26/2001
Decision Date01/29/2002
Product Code LPO 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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