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 lens model aa-4207vf. The device is to be placed in the capsular bag of the eye and is indicated for primary implantation for the visual correction of aphakia in persons 60 years of age or older in whom the cataractous lens has been removed by phacoemulsification or extracapsular cataract extraction.
| Device | UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S |
| Generic Name | Intraocular Lens |
| Applicant | STARR SURGICAL CO. |
| Date Received | 1997-03-26 |
| Decision Date | 1997-06-30 |
| PMA | P880091 |
| Supplement | S010 |
| 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 |