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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 POSTERIOD CHAMBER INTRAOCULAR LENS, MODEL Z9000 INTRAOCULAR LENS MD 911A
Generic Nameposterior chamber intraocular lenses
ApplicantPHARMACIA & UPJOHN CO.
PMA NumberP990080
Supplement NumberS001
Date Received09/05/2001
Decision Date10/16/2001
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new foldable, ultraviolet light-absorbing, posterior chamber intraocular lens model. The device, as modified, will be marketed under the trade name model z9000 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 phacoemulsification. The lens is intended to be placed in the capsular bag.
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