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 | SM-1, CR-1, & GR-1 IOLS |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES |
| Date Received | 1987-04-30 |
| Decision Date | 1987-11-03 |
| PMA | P840060 |
| Supplement | S004 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840060 | Original Filing | |
| S049 | 2021-06-21 | Normal 180 Day Track No User Fee |
| S048 | 2020-11-25 | 30-day Notice |
| S047 | 2019-07-05 | 30-day Notice |
| S046 | 2019-03-25 | 30-day Notice |
| S045 | 2019-03-25 | 30-day Notice |
| S044 | 2016-11-30 | 30-day Notice |
| S043 | 2016-08-03 | 30-day Notice |
| S042 | 2016-07-29 | 135 Review Track For 30-day Notice |
| S041 | 2015-12-09 | 30-day Notice |
| S040 | 2013-04-22 | 30-day Notice |
| S039 | 2012-12-26 | Normal 180 Day Track No User Fee |
| S038 | 2012-10-01 | 30-day Notice |
| S037 | 2011-06-24 | 30-day Notice |
| S036 | 2010-08-25 | 30-day Notice |
| S035 | 2010-08-10 | 30-day Notice |
| S034 | 2010-05-03 | 30-day Notice |
| S033 | 2010-05-03 | 30-day Notice |
| S032 | 2009-12-24 | 30-day Notice |
| S031 | 2009-06-30 | 30-day Notice |
| S030 | 2006-07-24 | 30-day Notice |
| S029 | 2004-10-18 | 135 Review Track For 30-day Notice |
| S028 | 2004-04-16 | Real-time Process |
| S027 | 1996-12-09 | Normal 180 Day Track |
| S026 | 1996-08-08 | Normal 180 Day Track |
| S025 | 1995-08-31 | Normal 180 Day Track |
| S024 | 1995-08-09 | Normal 180 Day Track |
| S023 | 1995-01-31 | Normal 180 Day Track |
| S022 | 1993-02-17 | Normal 180 Day Track |
| S021 | ||
| S020 | ||
| S019 | 1991-08-21 | Normal 180 Day Track |
| S018 | 1991-07-10 | Normal 180 Day Track |
| S017 | 1991-06-25 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 1989-04-05 | Normal 180 Day Track |
| S013 | ||
| S012 | 1988-12-30 | Normal 180 Day Track |
| S011 | 1988-12-29 | Normal 180 Day Track |
| S010 | 1988-08-29 | Normal 180 Day Track |
| S009 | ||
| S008 | 1988-01-20 | Normal 180 Day Track |
| S007 | 1987-11-25 | Normal 180 Day Track |
| S006 | 1987-11-12 | Normal 180 Day Track |
| S005 | 1987-10-16 | Normal 180 Day Track |
| S004 | 1987-04-30 | Normal 180 Day Track |
| S003 | 1986-09-26 | Normal 180 Day Track |
| S002 | 1986-04-08 | |
| S001 | 1985-11-05 |