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 | MODELS PC10 & PC21 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1989-03-17 |
| Decision Date | 1989-08-10 |
| PMA | P820049 |
| Supplement | S045 |
| Product Code | HQL |
| 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. 1700 East St. Andrew Pl. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820049 | Original Filing | |
| S064 | 1997-06-30 | Real-time Process |
| S063 | 1995-11-13 | Normal 180 Day Track |
| S062 | 1995-11-03 | Normal 180 Day Track |
| S061 | 1995-04-04 | Normal 180 Day Track |
| S060 | 1994-12-30 | Normal 180 Day Track |
| S059 | 1993-12-16 | Normal 180 Day Track |
| S058 | 1993-06-16 | Normal 180 Day Track |
| S057 | 1993-05-10 | Normal 180 Day Track |
| S056 | 1993-01-21 | Normal 180 Day Track |
| S055 | 1992-07-21 | Normal 180 Day Track |
| S054 | 1992-06-30 | Normal 180 Day Track |
| S053 | 1991-03-12 | Normal 180 Day Track |
| S052 | 1991-01-25 | Normal 180 Day Track |
| S051 | 1990-12-19 | Normal 180 Day Track |
| S050 | 1990-09-06 | Normal 180 Day Track |
| S049 | 1990-02-28 | Normal 180 Day Track |
| S048 | 1989-12-26 | Normal 180 Day Track |
| S047 | 1989-03-17 | Normal 180 Day Track |
| S046 | 1989-03-17 | Normal 180 Day Track |
| S045 | 1989-03-17 | Normal 180 Day Track |
| S044 | 1988-12-21 | Normal 180 Day Track |
| S043 | 1988-12-05 | Normal 180 Day Track |
| S042 | 1988-12-02 | Normal 180 Day Track |
| S041 | ||
| S040 | ||
| S039 | 1988-08-10 | Normal 180 Day Track |
| S038 | 1988-08-01 | Normal 180 Day Track |
| S037 | 1988-07-19 | Normal 180 Day Track |
| S036 | 1988-05-03 | Normal 180 Day Track |
| S035 | 1988-02-29 | Normal 180 Day Track |
| S034 | 1988-02-29 | Normal 180 Day Track |
| S033 | 1987-12-31 | Normal 180 Day Track |
| S032 | 1987-10-13 | Normal 180 Day Track |
| S031 | 1987-10-26 | Normal 180 Day Track |
| S030 | ||
| S029 | 1987-08-28 | Normal 180 Day Track |
| S028 | 1987-08-31 | Normal 180 Day Track |
| S027 | 1987-08-19 | Normal 180 Day Track |
| S026 | 1987-08-07 | Normal 180 Day Track |
| S025 | 1987-07-09 | Normal 180 Day Track |
| S024 | 1987-06-24 | Normal 180 Day Track |
| S023 | 1987-06-08 | Normal 180 Day Track |
| S022 | 1987-05-28 | Normal 180 Day Track |
| S021 | 1987-05-01 | Normal 180 Day Track |
| S020 | 1987-04-28 | Normal 180 Day Track |
| S019 | 1987-03-25 | Normal 180 Day Track |
| S018 | 1986-12-29 | Normal 180 Day Track |
| S017 | 1986-12-02 | Normal 180 Day Track |
| S016 | 1986-11-25 | Normal 180 Day Track |
| S015 | 1986-11-24 | Normal 180 Day Track |
| S014 | 1986-11-21 | Normal 180 Day Track |
| S013 | 1986-11-06 | Normal 180 Day Track |
| S012 | 1986-10-27 | Normal 180 Day Track |
| S011 | 1986-10-02 | Normal 180 Day Track |
| S010 | 1986-09-23 | Normal 180 Day Track |
| S009 | 1986-04-24 | |
| S008 | 1986-03-28 | |
| S007 | 1986-02-28 | |
| S006 | 1985-12-23 | |
| S005 | 1985-11-25 | |
| S004 | 1985-11-18 | |
| S003 | 1985-07-15 | |
| S002 | 1984-06-21 | |
| S001 | 1984-03-05 |