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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERFLUORON
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantALCON LABORATORIES
6201 SOUTH FREEWAY R3-48
FORT WORTH, TX 76134
PMA NumberP950018
Supplement NumberS007
Date Received07/13/2001
Decision Date08/07/2001
Product Code LWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES. THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.
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