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 an alternate sterilizatio process including aeration time and the establishment of the biol9ogical indicator incubation time
| Device | POSTERIOR CHAMBER IOL |
| Generic Name | Intraocular Lens |
| Applicant | ALCON LABORATORIES |
| Date Received | 1995-08-09 |
| Decision Date | 1995-12-13 |
| PMA | P840060 |
| Supplement | S024 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process 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 |