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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Generic Nameposterior chamber intraocular lenses
PMA NumberP960034
Date Received10/01/1996
Decision Date08/12/1998
Withdrawal Date 10/01/2009
Docket Number 98M-0725
Notice Date 10/27/1998
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for lens models with the heparin surface modification applied to all your single-piece pmma lenses approved in p810055. These models will be specified with a "c" following the number designation for the corresponding non-hsm pmma model. The lenses will be marketed under the trade name ceeon(tm) hsm pmma iols. This device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by an extracapsular cataract extraction (ecce) or phacoemulsification. They are intended to be placed in the capsular bag.
Supplements: S001 S002