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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.
 
DeviceBAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910061
Supplement NumberS006
Date Received12/01/1998
Decision Date12/14/1998
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a tumbling and an alternative extraction process to the manufacture of silicone lenses.
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