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.
| Device | C-Flex 570C, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses |
| Generic Name | Intraocular Lens |
| Applicant | RAYNER INTRAOCULAR LENSES LTD.1-2 Sackville Trading Estate,sackville Roadhove, East Sussex BN3 7 PMA NumberP060011 Supplement NumberS030 Date Received07/21/2022 Decision Date08/15/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-21 |
| Decision Date | 2022-08-15 |
| PMA | P060011 |
| Supplement | S030 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RAYNER INTRAOCULAR LENSES LTD. 1-2 Sackville Trading Estate, sackville Road hove, East Sussex BN3 7 PMA NumberP060011 Supplement NumberS030 Date Received07/21/2022 Decision Date08/15/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement changes To The Endotoxin Test Sample Preparation, Test Method, And Sampling Plan For Routine Release Testing |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060011 | Original Filing | |
| S030 | 2022-07-21 | 30-day Notice |
| S029 | ||
| S028 | 2021-07-06 | 30-day Notice |
| S027 | 2021-06-01 | 30-day Notice |
| S026 | 2021-02-01 | Real-time Process |
| S025 | 2020-08-14 | Normal 180 Day Track |
| S024 | 2020-05-26 | 30-day Notice |
| S023 | ||
| S022 | 2020-05-11 | 30-day Notice |
| S021 | 2020-04-27 | 30-day Notice |
| S020 | 2020-03-02 | 30-day Notice |
| S019 | 2020-01-27 | 30-day Notice |
| S018 | 2019-07-01 | 30-day Notice |
| S017 | 2019-03-20 | 30-day Notice |
| S016 | 2019-03-01 | 30-day Notice |
| S015 | ||
| S014 | 2018-04-02 | Normal 180 Day Track |
| S013 | 2017-11-13 | 30-day Notice |
| S012 | 2017-07-03 | Normal 180 Day Track No User Fee |
| S011 | 2017-04-21 | 30-day Notice |
| S010 | 2016-08-01 | 30-day Notice |
| S009 | 2016-05-09 | 30-day Notice |
| S008 | 2015-08-13 | 30-day Notice |
| S007 | 2015-06-05 | 135 Review Track For 30-day Notice |
| S006 | 2015-03-13 | 30-day Notice |
| S005 | 2015-02-02 | Real-time Process |
| S004 | 2012-05-29 | Real-time Process |
| S003 | 2012-02-06 | 30-day Notice |
| S002 | 2011-09-13 | Real-time Process |
| S001 | 2011-02-28 | 30-day Notice |