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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 NameSILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantPHARMACIA & UPJOHN CO.
PMA NumberP990080
Supplement NumberS002
Date Received09/13/2002
Decision Date09/24/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name for the model z9000 foldable posterior chamber intraocular lens, and other lens models which incorporate the modified prolate anterior optic surface. The device, as modified, will be marketed under the trade name technis, with z-sharp optic technology and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsifi-cation. The lens is intended to be placed in the capsular bag.
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