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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 NumberS004
Date Received08/18/2000
Decision Date09/05/2000
Product Code
LPO[ Registered Establishments with LPO ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the toxicity test protocol to increase the number of samples to be tested from each production lot of perfluoropropane from one sample per lot to three samples per lot.
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