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.
Changes to the mold tool used to produce the psc-60 injection cartridge tip for the 3-piece iol models
| Device | iSert Preloaded IOL System |
| Generic Name | Intraocular Lens |
| Applicant | HOYA SURGICAL OPTICS, INC. |
| Date Received | 2020-12-14 |
| Decision Date | 2021-01-13 |
| PMA | P080004 |
| Supplement | S039 |
| 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 | HOYA SURGICAL OPTICS, INC. 14768 Pipeline Avenue chino Hills, CA 91709 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080004 | Original Filing | |
| S043 | 2021-10-04 | Real-time Process |
| S042 | ||
| S041 | 2021-05-17 | 30-day Notice |
| S040 | 2021-04-12 | 30-day Notice |
| S039 | 2020-12-14 | 30-day Notice |
| S038 | 2020-12-14 | 30-day Notice |
| S037 | 2020-09-14 | 30-day Notice |
| S036 | ||
| S035 | ||
| S034 | 2020-03-18 | Real-time Process |
| S033 | ||
| S032 | 2020-02-12 | 30-day Notice |
| S031 | ||
| S030 | ||
| S029 | 2019-12-04 | 30-day Notice |
| S028 | ||
| S027 | 2019-11-01 | 30-day Notice |
| S026 | 2019-11-01 | 30-day Notice |
| S025 | 2019-09-04 | Real-time Process |
| S024 | 2019-07-23 | 30-day Notice |
| S023 | ||
| S022 | 2018-03-26 | 30-day Notice |
| S021 | 2018-01-05 | 30-day Notice |
| S020 | 2017-11-20 | 30-day Notice |
| S019 | 2017-11-08 | 135 Review Track For 30-day Notice |
| S018 | 2017-10-02 | 30-day Notice |
| S017 | 2017-04-10 | 135 Review Track For 30-day Notice |
| S016 | 2016-12-28 | Real-time Process |
| S015 | 2014-03-19 | Real-time Process |
| S014 | 2013-08-30 | 30-day Notice |
| S013 | 2012-12-19 | Real-time Process |
| S012 | 2012-05-29 | Real-time Process |
| S011 | 2012-05-18 | Normal 180 Day Track |
| S010 | 2011-12-23 | 30-day Notice |
| S009 | 2011-09-29 | 30-day Notice |
| S008 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S007 | 2011-04-27 | Real-time Process |
| S006 | 2011-03-08 | 30-day Notice |
| S005 | 2010-02-23 | 135 Review Track For 30-day Notice |
| S004 | 2010-01-21 | Normal 180 Day Track |
| S003 | ||
| S002 | 2009-02-24 | 135 Review Track For 30-day Notice |
| S001 | 2009-01-14 | Normal 180 Day Track |