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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.
 
DeviceSOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS007
Date Received11/24/1999
Decision Date12/16/1999
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approvalfor Model LI63U and to use MED-6812SH silicone material as an alternative to RMX-3 silicone for models with polyimide haptics approved under this PMA.
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