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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 NameMODEL 809A POTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantKABI PHARMACIA OPHTHALMICS, INC.
PMA NumberP810055
Supplement NumberS063
Date Received01/11/1993
Decision Date12/02/1994
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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