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. |
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Device | C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7 |
PMA Number | P060011 |
Supplement Number | S002 |
Date Received | 09/13/2011 |
Decision Date | 11/22/2011 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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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