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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
ApplicantSCOTT MEDICAL PRODUCTS GROUP
PMA NumberP900066
Supplement NumberS005
Date Received12/26/2001
Decision Date01/29/2002
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 labeling modifications to improve the patient's and doctor's knowledge regarding the hazards of using nitrous oxide for a subsequent surgical procedure when gas is still present in the eye.
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