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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
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 NumberS004
Date Received05/29/2012
Decision Date07/17/2012
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ASPHERIC OPTICAL SURFACE TO THE ANTERIOR SURFACE OF THE PARENT C-FLEX INTRAOCULAR LENS MODEL 570C (POWER RANGE +8.0 TO + 17.5 D).
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