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.
| Device | ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 1994-11-21 |
| Decision Date | 1995-02-08 |
| PMA | P880090 |
| Supplement | S016 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880090 | Original Filing | |
| S030 | 2019-01-04 | 30-day Notice |
| S029 | 2016-05-17 | 30-day Notice |
| S028 | ||
| S027 | 2009-11-02 | 30-day Notice |
| S026 | 2009-06-19 | 30-day Notice |
| S025 | 2008-06-19 | 30-day Notice |
| S024 | 2008-04-04 | Real-time Process |
| S023 | 2008-04-03 | 30-day Notice |
| S022 | ||
| S021 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S020 | 2004-03-18 | Real-time Process |
| S019 | 2003-06-23 | 30-day Notice |
| S018 | 2003-06-11 | Real-time Process |
| S017 | 1995-12-19 | Normal 180 Day Track |
| S016 | 1994-11-21 | Normal 180 Day Track |
| S015 | 1994-06-02 | Normal 180 Day Track |
| S014 | 1993-12-16 | Normal 180 Day Track |
| S013 | 1993-02-16 | Normal 180 Day Track |
| S012 | 1992-12-29 | Normal 180 Day Track |
| S011 | 1992-09-14 | Normal 180 Day Track |
| S010 | 1992-08-17 | Normal 180 Day Track |
| S009 | 1992-01-10 | Normal 180 Day Track |
| S008 | 1991-10-15 | Normal 180 Day Track |
| S007 | 1991-10-08 | Normal 180 Day Track |
| S006 | 1990-09-26 | Normal 180 Day Track |
| S005 | 1990-09-10 | Special (immediate Track) |
| S004 | 1990-06-06 | Normal 180 Day Track |
| S003 | 1990-02-02 | Normal 180 Day Track |
| S002 | 1988-12-22 | Normal 180 Day Track |
| S001 | 1988-12-19 | Normal 180 Day Track |