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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP910061
Supplement NumberS006
Date Received12/01/1998
Decision Date12/14/1998
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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