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 | SAUFLON(R) PW (LIDOFILCON B) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1988-05-19 |
| Decision Date | 1989-03-01 |
| PMA | P790020 |
| Supplement | S041 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 East St. Andrew Pl. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790020 | Original Filing | |
| S059 | 1998-10-13 | Real-time Process |
| S058 | 1998-06-25 | 30-day Notice |
| S057 | ||
| S056 | 1995-03-27 | Normal 180 Day Track |
| S055 | ||
| S054 | 1993-11-09 | Normal 180 Day Track |
| S053 | 1991-04-17 | Normal 180 Day Track |
| S052 | ||
| S051 | 1989-07-21 | Normal 180 Day Track |
| S050 | 1989-07-19 | Normal 180 Day Track |
| S049 | 1989-06-19 | Normal 180 Day Track |
| S048 | ||
| S047 | 1989-05-16 | Normal 180 Day Track |
| S046 | 1989-04-12 | Normal 180 Day Track |
| S045 | ||
| S044 | 1988-11-09 | Normal 180 Day Track |
| S043 | 1988-11-09 | Normal 180 Day Track |
| S042 | 1988-05-26 | Panel Track |
| S041 | 1988-05-19 | Normal 180 Day Track |
| S040 | 1988-04-27 | Special (immediate Track) |
| S039 | 1988-03-29 | Normal 180 Day Track |
| S038 | 1988-03-14 | Normal 180 Day Track |
| S037 | 1987-07-02 | Normal 180 Day Track |
| S036 | 1987-02-17 | 30-Day Supplement |
| S035 | 1987-01-20 | Normal 180 Day Track |
| S034 | 1986-04-02 | |
| S033 | 1985-11-25 | |
| S032 | 1985-09-06 | |
| S031 | 1985-03-25 | |
| S030 | 1984-10-01 | |
| S029 | 1984-07-02 | |
| S028 | 1984-06-26 | |
| S027 | 1984-05-30 | |
| S026 | ||
| S025 | 1984-05-17 | |
| S024 | 1984-05-15 | |
| S023 | 1984-02-06 | |
| S022 | 1984-01-11 | |
| S021 | 1984-01-10 | |
| S020 | ||
| S019 | 1983-11-30 | |
| S018 | 1983-11-23 | |
| S017 | 1983-10-06 | |
| S016 | ||
| S015 | 1983-09-09 | |
| S014 | ||
| S013 | 1983-07-01 | |
| S012 | 1983-06-08 | |
| S011 | 1983-06-08 | |
| S010 | 1982-06-15 | |
| S009 | 1982-09-29 | |
| S008 | 1982-08-26 | |
| S007 | ||
| S006 | 1982-05-18 | |
| S005 | 1982-05-03 | |
| S004 | 1981-12-04 | |
| S003 | 1981-09-21 | |
| S002 | 1981-09-01 | |
| S001 | 1980-05-02 |