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 | DURASOFT CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. |
| Date Received | 1988-12-16 |
| Decision Date | 1989-05-05 |
| PMA | N17852 |
| Supplement | S027 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17852 | Original Filing | |
| S033 | 1991-04-10 | Normal 180 Day Track |
| S032 | 1989-09-18 | Normal 180 Day Track |
| S031 | 1989-09-11 | Normal 180 Day Track |
| S030 | 1989-08-07 | Normal 180 Day Track |
| S029 | 1989-03-17 | Normal 180 Day Track |
| S028 | 1989-02-09 | Normal 180 Day Track |
| S027 | 1988-12-16 | Normal 180 Day Track |
| S026 | 1988-03-08 | Normal 180 Day Track |
| S025 | 1987-07-29 | Normal 180 Day Track |
| S024 | 1987-07-28 | Normal 180 Day Track |
| S023 | 1987-07-24 | Normal 180 Day Track |
| S022 | 1987-07-27 | Normal 180 Day Track |
| S021 | 1987-07-08 | 30-Day Supplement |
| S020 | 1987-06-08 | 30-Day Supplement |
| S019 | 1987-06-08 | 30-Day Supplement |
| S018 | 1987-05-22 | Normal 180 Day Track |
| S017 | 1987-05-22 | Normal 180 Day Track |
| S016 | 1986-10-08 | Special (immediate Track) |
| S015 | 1986-03-10 | Normal 180 Day Track |
| S014 | 1985-11-04 | |
| S013 | 1985-01-04 | |
| S012 | 1984-11-21 | |
| S011 | 1983-09-12 | |
| S010 | 1983-03-01 | |
| S009 | 1982-12-30 | |
| S008 | 1982-07-22 | |
| S007 | 1981-11-12 | |
| S006 | 1981-05-27 | |
| S005 | 1981-02-02 | |
| S004 | 1980-09-02 | |
| S003 | 1980-07-08 | |
| S002 | 1979-10-12 | |
| S001 | 1978-12-11 |