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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.
 
DevicePLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
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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