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.
Replacement of the current filter used during the filtering process of the rmx-3 silicone base material.
| Device | STAAR SURGICAL ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 2008-12-12 |
| Decision Date | 2009-01-09 |
| PMA | P880091 |
| Supplement | S029 |
| 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 |
|---|---|---|
| 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 |