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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.
 
DeviceIOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
1400 N. GOODMAN ST.
ROCHESTER, NY 14609
PMA NumberP850059
Supplement NumberS021
Date Received02/17/1999
Decision Date05/13/1999
Withdrawal Date 11/26/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing and sterilization facility located at Bausch & Lomb Surgical, Inc., 21 Park Place Blvd., North, Clearwater, FL 33759.
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