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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceC-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantRAYNER INTRAOCULAR LENSES LTD.
1-2 SACKVILLE TRADING ESTATE,
SACKVILLE ROAD
HOVE, EAST SUSSEX BN3 7
PMA NumberP060011
Supplement NumberS002
Date Received09/13/2011
Decision Date11/22/2011
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 570C, AS WELL AS THE ADDITION OF A MODULATION TRANSFER FUNCTION (MTF) FIGURE TO THE PHYSICIANS LABELING COMPARING BOTH MODELS (I.E., 970C AND 570C).
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