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 to revise the directions for use insert to recommend an add'l insertion instrument, the microstaar(tm) injection system (models msi-td and msi-pd)
| Device | UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 1996-03-21 |
| Decision Date | 1997-04-04 |
| PMA | P880091 |
| Supplement | S007 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |