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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 IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
50 Technology Drive
Irvine, CA 92618
PMA NumberP910061
Supplement NumberS008
Date Received02/10/1999
Decision Date03/15/1999
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for minor revision to the labeling and an alternate sterilization method.
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