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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 NumberS067
Date Received03/06/1997
Decision Date05/28/1997
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
Approval Order Statement 
Approval for tier a posterior chamber intraocular lens model 777a. This intraocular lens is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.
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