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 a new manufacturing facility located at bausch & lomb, inc. Wilmington, massachusetts. The clear compression molded blank pmma material will be manufactured at this facility.
| Device | PMMA INTAOCULAR LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Bausch & Lomb, Inc. |
| Date Received | 2002-04-08 |
| Decision Date | 2002-05-21 |
| PMA | P840039 |
| Supplement | S050 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bausch & Lomb, Inc. 50 Technology irvine, CA 92618 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840039 | Original Filing | |
| S064 | 2022-07-11 | 30-day Notice |
| S063 | 2019-01-04 | 30-day Notice |
| S062 | 2017-06-15 | 30-day Notice |
| S061 | 2016-05-17 | 30-day Notice |
| S060 | ||
| S059 | 2009-11-02 | 30-day Notice |
| S058 | 2009-06-19 | 30-day Notice |
| S057 | 2008-06-19 | 30-day Notice |
| S056 | 2008-04-03 | 30-day Notice |
| S055 | 2005-11-22 | Real-time Process |
| S054 | 2004-03-29 | Normal 180 Day Track No User Fee |
| S053 | 2004-03-18 | Real-time Process |
| S052 | 2003-06-23 | 30-day Notice |
| S051 | 2003-06-11 | Real-time Process |
| S050 | 2002-04-08 | Normal 180 Day Track |
| S049 | 1995-12-19 | Normal 180 Day Track |
| S048 | 1995-10-10 | Normal 180 Day Track |
| S047 | 1994-11-21 | Normal 180 Day Track |
| S046 | 1994-06-02 | Normal 180 Day Track |
| S045 | 1993-10-05 | Normal 180 Day Track |
| S044 | 1993-08-18 | Normal 180 Day Track |
| S043 | 1993-04-02 | Normal 180 Day Track |
| S042 | 1993-02-16 | Normal 180 Day Track |
| S041 | 1992-09-14 | Normal 180 Day Track |
| S040 | 1992-09-04 | Normal 180 Day Track |
| S039 | 1992-08-27 | Normal 180 Day Track |
| S038 | 1992-08-27 | Normal 180 Day Track |
| S037 | 1992-05-15 | Normal 180 Day Track |
| S036 | 1992-03-03 | Normal 180 Day Track |
| S035 | 1992-01-29 | Normal 180 Day Track |
| S034 | 1992-01-17 | Normal 180 Day Track |
| S033 | ||
| S032 | 1991-10-08 | Normal 180 Day Track |
| S031 | 1991-08-19 | Normal 180 Day Track |
| S030 | 1991-08-19 | Normal 180 Day Track |
| S029 | 1990-03-30 | Normal 180 Day Track |
| S028 | 1990-02-02 | Normal 180 Day Track |
| S027 | ||
| S026 | ||
| S025 | ||
| S024 | ||
| S023 | ||
| S022 | 1988-12-12 | Normal 180 Day Track |
| S021 | 1988-12-08 | Normal 180 Day Track |
| S020 | ||
| S019 | ||
| S018 | 1988-11-25 | Normal 180 Day Track |
| S017 | ||
| S016 | ||
| S015 | 1988-11-25 | Normal 180 Day Track |
| S014 | ||
| S013 | 1988-11-25 | Normal 180 Day Track |
| S012 | 1988-11-18 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | ||
| S007 | 1988-09-30 | Normal 180 Day Track |
| S006 | 1988-08-01 | Panel Track |
| S005 | ||
| S004 | ||
| S003 | 1987-07-30 | Normal 180 Day Track |
| S002 | 1987-03-16 | Normal 180 Day Track |
| S001 |