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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 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP950018
Supplement NumberS009
Date Received02/14/2003
Decision Date03/20/2003
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW STABILITY PROTOCOL THAT WILL EXTEND THE EXPIRATION DATING FOR PERFLUORON FROM 2 YEARS TO UP TO 4 YEARS FOR THE CURRENTLY APPROVED PRODUCT CONFIGURATION, WITH STABILITY TESTING DATA REPORTED VIA ANNUAL REPORTS IN THE FUTURE.
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