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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.
 
DeviceRayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses
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 NumberS014
Date Received04/02/2018
Decision Date11/14/2018
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for manufacturing process improvements for all Rayner FDA-approved Intraocular Lenses (IOLs) and a new packaging configuration for your 6.0 mm Aspheric IOL, Model 600C, into a preloaded injector.
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