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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.
 
Trade NameMEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL U940A)
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantIOLTECH, S.A.
PMA NumberP960036
Date Received10/01/1996
Decision Date12/22/1997
Withdrawal Date 10/12/2006
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 98M-0137
Notice Date 03/04/1998
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the memorylens(tm) model u940a ultraviolet-absorbing hydrophilic posterior chamber intraocular lens. This device is indicated for primary implantation for the visual correction of aphakia in patients sixty years of age or older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
Supplements: S001 S002 S003 S004 S005 S006 
S007 
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