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 | SOFTMATE SOLUTION |
| Classification Name | Accessories, Soft Lens Products |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1986-11-07 |
| Decision Date | 1986-12-04 |
| PMA | N18073 |
| Supplement | S014 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N18073 | Original Filing | |
| S024 | 1995-01-27 | Normal 180 Day Track |
| S023 | 1992-10-26 | Normal 180 Day Track |
| S022 | 1990-11-21 | Normal 180 Day Track |
| S021 | ||
| S020 | 1990-03-27 | Normal 180 Day Track |
| S019 | 1990-01-30 | Normal 180 Day Track |
| S018 | 1989-10-13 | Normal 180 Day Track |
| S017 | 1987-11-30 | Normal 180 Day Track |
| S016 | ||
| S015 | 1987-01-29 | Normal 180 Day Track |
| S014 | 1986-11-07 | 30-Day Supplement |
| S013 | 1986-11-06 | 30-Day Supplement |
| S012 | 1986-09-18 | Normal 180 Day Track |
| S011 | 1986-09-02 | Normal 180 Day Track |
| S010 | ||
| S009 | 1986-06-11 | Normal 180 Day Track |
| S008 | 1985-08-12 | |
| S007 | 1985-08-12 | |
| S006 | 1985-04-08 | |
| S005 | ||
| S004 | 1983-06-07 | |
| S003 | 1982-04-13 | |
| S002 | 1980-02-05 | |
| S001 | 1979-06-23 |