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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 POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantPHARMACIA, INC.
PMA NumberP810055
Supplement NumberS069
Date Received03/27/1998
Decision Date12/03/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of uvex 326 polymethylmethacrylate (pmma) material in the manufacture of one-piece pmma posterior chamber intraocular lenses (iols) approved under p810055.
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