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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 NamePERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
Classification Namegases used within eye to place pressure on detached retina
Regulation Number886.4270
ApplicantAIR LIQUIDE
PMA NumberP900066
Supplement NumberS006
Date Received08/13/2002
Decision Date12/10/2002
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 to add a molecular sieve scrubbing step at the end of the gas manufacturing process.
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