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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.
 
DeviceMODEL 3091B IOL /W 5.0 MM OPTICS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP790027
Supplement NumberS056
Date Received02/18/1992
Decision Date11/17/1993
Withdrawal Date 11/26/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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