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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
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE
PMA NumberP900066
Supplement NumberS008
Date Received07/21/2008
Decision Date02/19/2009
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change of perfluoropropane gas supplier.
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