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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
Generic Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE HEALTHCARE AMERICA CORPORATION
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 - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change of perfluoropropane gas supplier.
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