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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameISPAN SULFUR HEXAFLUORIDE SF6 GAS
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE HEALTHCARE
PMA NumberP900067
Supplement NumberS006
Date Received08/13/2009
Decision Date01/13/2010
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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