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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 SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES WITH PLATE HAPTICS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP910058
Supplement NumberS010
Date Received09/09/1999
Decision Date05/09/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the manufacturing facility located at bausch & lomb surgical, clearwater, florida.
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