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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 NameC-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRAYNER INTRAOCULAR LENSES LTD.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 
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