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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 NamePLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL
Classification Nameintraocular lens
Generic Nameuv absorbing iol
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP940007
Date Received02/28/1994
Decision Date07/20/1995
Withdrawal Date 01/22/2008
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 95m-0395
Notice Date 12/19/1995
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model ws-100 pliolens ultraviolet-absorbing silicone posterior chamber intraocular lens.
Supplements: S001 S002 S004 S005 S006 
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