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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 NameCOLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber iol
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP990013
Date Received03/05/1999
Decision Date04/02/2000
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 00M-1230
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
This device is indicated for the correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
Approval Order Approval Order
Supplements: S001 S003 S004 S006 S007 S008 
S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 
S027 S028 S029 S030 S031 
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