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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.
 
DeviceISPAN SULFUR HEXAFLUORIDE SF6 GAS
Generic NameGases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAirgas Therapeutics, LLC
6141 Easton Rd.
Plumsteadville, PA 18949
PMA NumberP900067
Supplement NumberS006
Date Received08/13/2009
Decision Date01/13/2010
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
Predetermined Change Control Plan AuthorizedNo
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.
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