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.
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.
| Device | Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | RAYNER INTRAOCULAR LENSES LTD. |
| Date Received | 2018-04-02 |
| Decision Date | 2018-11-14 |
| PMA | P060011 |
| Supplement | S014 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |
| 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 |