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.
Change in the blister tray and foil lid material specification.
| Device | RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES |
| Applicant | RAYNER INTRAOCULAR LENSES LTD. |
| Date Received | 2015-08-13 |
| Decision Date | 2015-09-09 |
| PMA | P060011 |
| Supplement | S008 |
| 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 |
| 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 |