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) 70 (LIDOFILCON A) |
Classification Name | Lenses, Soft Contact, Extended Wear |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | ADVANCED MEDICAL OPTICS, INC. |
Date Received | 1981-09-01 |
Decision Date | 1982-09-23 |
Notice Date | 1985-05-10 |
PMA | P790020 |
Supplement | S002 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
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 |