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.
Addition of an autoclave for use in the sterilization of the visian implantable collamer lens (icl) and the collamer intraocular lens (ciol) at the monrovia, california facility.
| Device | Visian Implantable Collamer Lens for Myopia |
| Classification Name | Lens, Intraocular, Phakic |
| Generic Name | Lens, Intraocular, Phakic |
| Applicant | STAAR Surgical Company |
| Date Received | 2017-07-06 |
| Decision Date | 2017-08-04 |
| PMA | P030016 |
| Supplement | S033 |
| Product Code | MTA |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STAAR Surgical Company 1911 Walker Ave. monrovia, CA 91016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030016 | Original Filing | |
| S043 | 2022-04-04 | Normal 180 Day Track No User Fee |
| S042 | ||
| S041 | 2021-06-22 | 30-day Notice |
| S040 | 2020-03-03 | 30-day Notice |
| S039 | 2019-06-27 | 30-day Notice |
| S038 | 2019-05-21 | Normal 180 Day Track No User Fee |
| S037 | ||
| S036 | 2018-11-02 | Normal 180 Day Track No User Fee |
| S035 | ||
| S034 | 2018-10-11 | Normal 180 Day Track No User Fee |
| S033 | 2017-07-06 | 30-day Notice |
| S032 | 2017-06-27 | 30-day Notice |
| S031 | 2017-05-19 | 30-day Notice |
| S030 | 2017-01-05 | 30-day Notice |
| S029 | 2015-11-12 | 30-day Notice |
| S028 | 2015-10-19 | 30-day Notice |
| S027 | 2014-04-14 | Normal 180 Day Track |
| S026 | 2014-01-13 | 30-day Notice |
| S025 | 2013-03-12 | Normal 180 Day Track No User Fee |
| S024 | ||
| S023 | 2012-02-29 | Normal 180 Day Track No User Fee |
| S022 | 2011-12-16 | Normal 180 Day Track No User Fee |
| S021 | ||
| S020 | 2011-03-30 | 30-day Notice |
| S019 | 2010-12-23 | Normal 180 Day Track |
| S018 | 2010-10-14 | Normal 180 Day Track No User Fee |
| S017 | 2010-08-17 | Special (immediate Track) |
| S016 | 2010-07-15 | 30-day Notice |
| S015 | 2010-06-25 | 30-day Notice |
| S014 | 2010-05-17 | 30-day Notice |
| S013 | ||
| S012 | 2009-02-09 | 30-day Notice |
| S011 | 2008-10-09 | 30-day Notice |
| S010 | 2008-08-04 | 30-day Notice |
| S009 | 2008-07-23 | 135 Review Track For 30-day Notice |
| S008 | 2008-06-06 | 30-day Notice |
| S007 | 2008-04-25 | 30-day Notice |
| S006 | 2008-04-02 | Normal 180 Day Track |
| S005 | 2008-03-28 | 30-day Notice |
| S004 | 2008-03-20 | 30-day Notice |
| S003 | 2008-02-22 | 30-day Notice |
| S002 | ||
| S001 | 2006-04-28 | Panel Track |