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 the microbiology laboratory at the staar surgical, monrovia facility, as an alternate provider of environmental monitoring services for cleanrooms used to manufacture and process finished devices
| Device | Collamer Intraocular Lens - Alternat Environmental Monitoring Provider |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 2019-06-27 |
| Decision Date | 2019-07-26 |
| PMA | P990013 |
| 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 | STARR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990013 | Original Filing | |
| S041 | 2021-06-22 | 30-day Notice |
| S040 | 2020-03-03 | 30-day Notice |
| S039 | 2019-06-27 | 30-day Notice |
| S038 | 2019-04-22 | Real-time Process |
| S037 | 2017-07-06 | 30-day Notice |
| S036 | 2017-07-03 | 30-day Notice |
| S035 | 2017-05-19 | 30-day Notice |
| S034 | 2017-03-13 | 30-day Notice |
| S033 | 2014-01-13 | 30-day Notice |
| S032 | ||
| S031 | 2011-03-30 | 30-day Notice |
| S030 | 2010-12-14 | 30-day Notice |
| S029 | 2010-08-17 | Special (immediate Track) |
| S028 | 2010-07-15 | 30-day Notice |
| S027 | 2010-06-25 | 30-day Notice |
| S026 | 2010-05-17 | 30-day Notice |
| S025 | 2009-02-09 | 30-day Notice |
| S024 | 2008-10-09 | 30-day Notice |
| S023 | 2008-08-04 | 30-day Notice |
| S022 | 2008-07-23 | 135 Review Track For 30-day Notice |
| S021 | 2008-06-06 | 30-day Notice |
| S020 | 2008-05-05 | 30-day Notice |
| S019 | 2008-04-25 | 30-day Notice |
| S018 | 2008-04-02 | Normal 180 Day Track |
| S017 | 2008-03-28 | 30-day Notice |
| S016 | 2008-03-20 | 30-day Notice |
| S015 | 2008-02-22 | 30-day Notice |
| S014 | 2007-11-29 | Real-time Process |
| S013 | 2007-05-04 | Special (immediate Track) |
| S012 | 2007-02-26 | 30-day Notice |
| S011 | 2007-02-26 | 30-day Notice |
| S010 | 2007-02-23 | 30-day Notice |
| S009 | 2007-02-23 | 135 Review Track For 30-day Notice |
| S008 | 2007-02-22 | 30-day Notice |
| S007 | 2007-02-22 | 30-day Notice |
| S006 | 2007-02-22 | 30-day Notice |
| S005 | ||
| S004 | 2004-05-24 | Special (immediate Track) |
| S003 | 2001-07-06 | 30-day Notice |
| S002 | ||
| S001 | 2000-07-24 | Normal 180 Day Track |