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 a change in the approved polycarbonate packaging material that is in direct contact with the lens during steam sterilization and throughout the shelf-life of the lens.
| Device | SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 2007-11-09 |
| Decision Date | 2007-12-04 |
| PMA | P880091 |
| Supplement | S023 |
| 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 |
|---|---|---|
| P880091 | Original Filing | |
| S032 | 2010-08-17 | Special (immediate Track) |
| S031 | ||
| S030 | 2008-01-15 | 30-day Notice |
| S029 | 2008-12-12 | 30-day Notice |
| S028 | 2008-07-23 | 135 Review Track For 30-day Notice |
| S027 | 2008-07-18 | 30-day Notice |
| S026 | 2008-04-16 | 30-day Notice |
| S025 | 2008-04-02 | Real-time Process |
| S024 | 2007-12-17 | 30-day Notice |
| S023 | 2007-11-09 | Real-time Process |
| S022 | 2007-04-17 | 30-day Notice |
| S021 | 2007-03-01 | 30-day Notice |
| S020 | 2007-02-26 | 30-day Notice |
| S019 | 2005-09-28 | 30-day Notice |
| S018 | 2005-06-03 | 30-day Notice |
| S017 | 1999-07-30 | 30-day Notice |
| S016 | 1999-01-22 | Normal 180 Day Track |
| S015 | 1998-09-17 | Normal 180 Day Track |
| S014 | 1997-12-16 | Panel Track |
| S013 | ||
| S012 | 1997-08-19 | Normal 180 Day Track |
| S011 | 1997-08-14 | Normal 180 Day Track |
| S010 | 1997-03-26 | Real-time Process |
| S009 | 1996-05-28 | Normal 180 Day Track |
| S008 | 1996-04-18 | Normal 180 Day Track |
| S007 | 1996-03-21 | Normal 180 Day Track |
| S006 | 1995-12-04 | Normal 180 Day Track |
| S005 | 1995-10-03 | Normal 180 Day Track |
| S004 | 1992-12-18 | Normal 180 Day Track |
| S003 | 1992-06-04 | Normal 180 Day Track |
| S002 | 1992-04-23 | Normal 180 Day Track |
| S001 |