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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.
 
DeviceACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP880087
Supplement NumberS010
Date Received04/16/2004
Decision Date04/29/2004
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE INDICATIONS STATEMENT, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER WHEN EXTRACAPSULAR CATARACT EXTRACTION OR PHACOEMULSIFICATION ARE PERFORMED OR WHERE A CATARACTOUS LENS HAS BEEN REMOVED. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULTS FOLLOWING CATARACT SURGERY.
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