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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceC-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRAYNER INTRAOCULAR LENSES LTD.
1-2 SACKVILLE TRADING ESTATE,
SACKVILLE ROAD
HOVE, EAST SUSSEX BN3 7
PMA NumberP060011
Date Received03/15/2006
Decision Date05/03/2007
Product Code HQL 
Docket Number 07M-0189
Notice Date 05/11/2007
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE C-FLEX MODEL 570C INTRAOCULAR LENS (IOL). THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICA-TION. THE LENS IS INTENDED TO BE PLACE IN THE CAPSULAR BAG.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S030 S033 S034 S035 S036 
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