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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 PERFLUOROPROPANE C3F8 GAS
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE HEALTHCARE
PMA NumberP900066
Supplement NumberS010
Date Received07/19/2010
Decision Date08/18/2010
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change of the cleaning solvent used in the perfluoropropane gas manufacturing process.
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