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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 No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
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 S033 
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