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 | SOFTHERM SOL. |
| Classification Name | Accessories, Soft Lens Products |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1987-10-22 |
| Decision Date | 1988-03-15 |
| PMA | N18078 |
| Supplement | S035 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N18078 | Original Filing | |
| S049 | 1995-01-27 | Normal 180 Day Track |
| S048 | 1992-11-19 | Normal 180 Day Track |
| S047 | 1990-11-21 | Normal 180 Day Track |
| S046 | ||
| S045 | 1990-03-27 | Normal 180 Day Track |
| S044 | 1989-10-12 | Normal 180 Day Track |
| S043 | 1989-09-07 | Normal 180 Day Track |
| S042 | 1989-07-31 | Normal 180 Day Track |
| S041 | 1989-05-19 | Normal 180 Day Track |
| S040 | 1988-07-28 | Normal 180 Day Track |
| S039 | 1988-06-16 | Normal 180 Day Track |
| S038 | 1988-01-05 | Normal 180 Day Track |
| S037 | 1987-11-30 | Normal 180 Day Track |
| S036 | 1987-11-30 | Normal 180 Day Track |
| S035 | 1987-10-22 | Normal 180 Day Track |
| S034 | 1987-09-15 | Normal 180 Day Track |
| S033 | 1987-07-09 | Normal 180 Day Track |
| S032 | 1987-05-27 | Normal 180 Day Track |
| S031 | 1987-05-15 | Normal 180 Day Track |
| S030 | 1987-01-29 | Normal 180 Day Track |
| S029 | 1986-11-07 | 30-Day Supplement |
| S028 | 1986-08-22 | Normal 180 Day Track |
| S027 | 1986-07-02 | Normal 180 Day Track |
| S026 | 1986-06-11 | Normal 180 Day Track |
| S025 | 1986-05-20 | Normal 180 Day Track |
| S024 | 1986-05-20 | Normal 180 Day Track |
| S023 | 1986-03-24 | |
| S022 | 1986-03-13 | |
| S021 | 1986-01-21 | |
| S020 | 1985-12-13 | |
| S019 | 1985-04-09 | |
| S018 | 1985-07-23 | |
| S017 | 1985-07-05 | |
| S016 | 1985-04-08 | |
| S015 | 1985-01-23 | |
| S014 | 1985-01-02 | |
| S013 | 1984-08-27 | |
| S012 | 1984-05-03 | |
| S011 | ||
| S010 | 1984-01-04 | |
| S009 | 1983-05-16 | |
| S008 | 1983-04-28 | |
| S007 | 1982-06-17 | |
| S006 | 1982-04-13 | |
| S005 | 1981-04-13 | |
| S004 | 1981-04-06 | |
| S003 | 1980-07-24 | |
| S002 | 1979-08-09 | |
| S001 | 1979-07-31 |