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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 NameUV ABSORBING PMMA ANTERIOR AND POSTERIOR CHAMBER IOLS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP850059
Supplement NumberS020
Date Received02/10/1999
Decision Date03/15/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor revision to the labeling and an alternate sterilization method.
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