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 parametric lot release using existing validated steam sterilization cycles. The device, as modified, will be marketed under the trade name collamer ultraviolet-absorbing posterior chamber intraocular lens and is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).
| Device | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 2007-11-29 |
| Decision Date | 2008-01-25 |
| PMA | P990013 |
| Supplement | S014 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |