This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the durasoft 3 (phemfilcon a) extended wear hydrophilic contact lens. The lens is indicated for up to 14 days of continuous wear between cleaning and disinfection (extended wear) by persons with eyes that are non-diseased, not-aphakic, have no more than 2. 00 diopters (d) of astigmatism, and require a spherical lens in the power range from -20. 00 d to +0. 00 d for the correction of nearsightedness (myopia) or farsightedness (hyperopia). The lens is to be disinfected using either a heat (thermal) or a chemical (not heat) disinfection system.
| Device | DURASOFT(R) 3 FOR EXT WEAR |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 1983-07-07 |
| Decision Date | 1984-04-24 |
| Notice Date | 1984-05-31 |
| PMA | P830037 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 84M-0164 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830037 | Original Filing | |
| S054 | 2012-10-04 | 30-day Notice |
| S053 | 2011-09-23 | Normal 180 Day Track |
| S052 | 2011-03-21 | 30-day Notice |
| S051 | 2010-12-13 | 30-day Notice |
| S050 | ||
| S049 | ||
| S048 | 2003-02-07 | Real-time Process |
| S047 | 2002-10-25 | Real-time Process |
| S046 | 2002-07-16 | Normal 180 Day Track |
| S045 | 2002-03-28 | Real-time Process |
| S044 | 2001-03-05 | 135 Review Track For 30-day Notice |
| S043 | 2000-10-10 | Normal 180 Day Track |
| S042 | 1999-04-07 | Real-time Process |
| S041 | 1998-07-06 | Normal 180 Day Track |
| S040 | 1996-12-18 | Normal 180 Day Track |
| S039 | 1995-10-02 | Normal 180 Day Track |
| S038 | 1994-05-01 | 30-Day Supplement |
| S037 | 1994-04-11 | Normal 180 Day Track |
| S036 | 1994-03-28 | Normal 180 Day Track |
| S035 | 1993-08-13 | Normal 180 Day Track |
| S034 | 1993-02-26 | Normal 180 Day Track |
| S033 | 1991-05-31 | Normal 180 Day Track |
| S032 | 1991-04-10 | Normal 180 Day Track |
| S031 | 1989-09-18 | Normal 180 Day Track |
| S030 | 1989-09-11 | Normal 180 Day Track |
| S029 | 1989-09-05 | Normal 180 Day Track |
| S028 | 1989-08-07 | Normal 180 Day Track |
| S027 | 1989-08-01 | Normal 180 Day Track |
| S026 | 1989-07-20 | Normal 180 Day Track |
| S025 | 1989-06-19 | Normal 180 Day Track |
| S024 | 1989-03-17 | Normal 180 Day Track |
| S023 | 1989-02-09 | Normal 180 Day Track |
| S022 | 1988-12-16 | Normal 180 Day Track |
| S021 | 1987-07-29 | Normal 180 Day Track |
| S020 | 1987-07-30 | Normal 180 Day Track |
| S019 | 1987-07-27 | Normal 180 Day Track |
| S018 | 1987-07-28 | Normal 180 Day Track |
| S017 | ||
| S016 | 1987-07-27 | Normal 180 Day Track |
| S015 | 1987-06-08 | Normal 180 Day Track |
| S014 | 1987-05-20 | Normal 180 Day Track |
| S013 | 1987-04-09 | Normal 180 Day Track |
| S012 | 1987-01-15 | Normal 180 Day Track |
| S011 | 1986-12-15 | Normal 180 Day Track |
| S010 | 1986-12-15 | Normal 180 Day Track |
| S009 | 1986-10-08 | Special (immediate Track) |
| S008 | 1985-11-04 | |
| S007 | 1985-10-04 | |
| S006 | 1985-07-23 | |
| S005 | 1985-06-18 | 30-Day Supplement |
| S004 | 1984-11-21 | |
| S003 | 1984-06-21 | |
| S002 | ||
| S001 | 1984-04-27 |