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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.
 
DevicePOLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
1400 N. GOODMAN ST.
ROCHESTER, NY 14609
PMA NumberP850059
Supplement NumberS024
Date Received06/11/2003
Decision Date08/13/2003
Withdrawal Date 11/26/2008
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 DIRECTIONS FOR USE FOR ALL LEGALLY MARKETED IOLS UNDER THE REFERENCED PMAS, TO INDICATE THE IOLS FOR USE IN ADULT PATIENTS. PREVIOUSLY, THE IOLS WERE INDICATED FOR USE IN PERSONS 60 YEARS OF AGE OR OLDER. THESE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THEIR APPROVED TRADE NAMES AND ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS.
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