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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.
 
DeviceC-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
RAYNER 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[ Registered Establishments with HQL ]
Docket Number 07M-0189
Notice Date 05/11/2007
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 
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