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.
This device is indicated for improving uncorrected visual acuity, correcting aphakia and decreasing refractive cylinder resulting from corneal astigmatism in persons aged 60 and over.
| Device | UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC |
| Generic Name | Lens, Intraocular, Toric Optics |
| Applicant | STARR SURGICAL CO. |
| Date Received | 1997-12-16 |
| Decision Date | 1998-11-04 |
| Notice Date | 1998-12-17 |
| PMA | P880091 |
| Supplement | S014 |
| Product Code | MJP |
| Docket Number | 98M-0998 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| 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 |