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 | MODELS B-13F (P-10) & B-1H (P-11) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES |
| Date Received | 1983-06-17 |
| Decision Date | 1983-07-27 |
| PMA | P810032 |
| Supplement | S003 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810032 | Original Filing | |
| S070 | 2019-07-05 | 30-day Notice |
| S069 | 2019-03-25 | 30-day Notice |
| S068 | 2019-03-25 | 30-day Notice |
| S067 | 2016-11-30 | 30-day Notice |
| S066 | 2016-08-03 | 30-day Notice |
| S065 | 2016-07-29 | 135 Review Track For 30-day Notice |
| S064 | 2015-12-09 | 30-day Notice |
| S063 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S062 | 2012-10-01 | 30-day Notice |
| S061 | 2012-05-29 | 30-day Notice |
| S060 | 2011-06-24 | 30-day Notice |
| S059 | 2010-08-25 | 30-day Notice |
| S058 | 2010-08-10 | 30-day Notice |
| S057 | 2010-05-03 | 30-day Notice |
| S056 | 2010-05-03 | 30-day Notice |
| S055 | 2009-12-24 | 30-day Notice |
| S054 | 2009-06-30 | 30-day Notice |
| S053 | 2007-01-16 | 30-day Notice |
| S052 | 2006-07-24 | 30-day Notice |
| S051 | 2004-10-18 | 135 Review Track For 30-day Notice |
| S050 | 2004-04-16 | Real-time Process |
| S049 | 1996-08-08 | Normal 180 Day Track |
| S048 | 1995-08-09 | Normal 180 Day Track |
| S047 | 1995-01-31 | |
| S046 | ||
| S045 | 1993-02-17 | Normal 180 Day Track |
| S044 | 1992-04-16 | Normal 180 Day Track |
| S043 | 1991-08-21 | Normal 180 Day Track |
| S042 | 1991-07-10 | Normal 180 Day Track |
| S041 | 1991-06-25 | Normal 180 Day Track |
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | ||
| S036 | ||
| S035 | ||
| S034 | ||
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | 1988-12-29 | Normal 180 Day Track |
| S029 | ||
| S028 | 1988-12-22 | Normal 180 Day Track |
| S027 | 1988-11-23 | Normal 180 Day Track |
| S026 | 1988-11-14 | Normal 180 Day Track |
| S025 | 1988-11-08 | Normal 180 Day Track |
| S024 | 1988-08-30 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1988-06-28 | Normal 180 Day Track |
| S020 | 1988-05-31 | Normal 180 Day Track |
| S019 | ||
| S018 | ||
| S017 | 1988-05-09 | Normal 180 Day Track |
| S016 | 1987-12-24 | Normal 180 Day Track |
| S015 | 1987-12-14 | Normal 180 Day Track |
| S014 | 1987-12-14 | Normal 180 Day Track |
| S013 | 1987-05-18 | Normal 180 Day Track |
| S012 | 1987-04-15 | Normal 180 Day Track |
| S011 | 1986-12-22 | Normal 180 Day Track |
| S010 | 1986-08-14 | Normal 180 Day Track |
| S009 | ||
| S008 | 1986-01-23 | |
| S007 | 1985-12-24 | |
| S006 | 1985-08-09 | |
| S005 | 1984-01-26 | |
| S004 | 1983-07-21 | |
| S003 | 1983-06-17 | |
| S002 | ||
| S001 | 1982-12-28 |