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Device | C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) |
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 |
Date Received | 03/15/2006 |
Decision Date | 05/03/2007 |
Product Code |
HQL |
Docket Number | 07M-0189 |
Notice Date | 05/11/2007 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S030 S033 S034 S035 S036 |