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.
Approval to modify the "indications" statements for all legally marketed iols under the above referenced pmas to reflect adults as opposed to adults older than 60 years of age.
| Device | CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 2005-01-03 |
| Decision Date | 2005-02-04 |
| PMA | P810055 |
| Supplement | S071 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810055 | Original Filing | |
| S072 | 2008-05-29 | 30-day Notice |
| S071 | 2005-01-03 | Real-time Process |
| S070 | 1998-06-23 | Real-time Process |
| S069 | 1998-03-27 | Normal 180 Day Track |
| S068 | 1997-05-14 | Normal 180 Day Track |
| S067 | 1997-03-06 | Normal 180 Day Track |
| S066 | 1996-05-23 | Normal 180 Day Track |
| S065 | ||
| S064 | ||
| S063 | 1993-01-11 | Normal 180 Day Track |
| S062 | ||
| S061 | 1992-09-14 | Normal 180 Day Track |
| S060 | ||
| S059 | 1992-08-10 | Normal 180 Day Track |
| S058 | 1992-08-10 | Normal 180 Day Track |
| S057 | 1992-08-04 | Normal 180 Day Track |
| S056 | 1992-07-17 | Normal 180 Day Track |
| S055 | 1992-05-26 | Normal 180 Day Track |
| S054 | 1992-04-15 | Normal 180 Day Track |
| S053 | 1992-04-09 | Normal 180 Day Track |
| S052 | 1991-08-09 | Normal 180 Day Track |
| S051 | 1991-04-15 | Normal 180 Day Track |
| S050 | 1991-01-08 | Normal 180 Day Track |
| S049 | ||
| S048 | ||
| S047 | 1990-06-29 | Normal 180 Day Track |
| S046 | ||
| S045 | ||
| S044 | 1990-03-26 | Normal 180 Day Track |
| S043 | 1990-03-12 | Normal 180 Day Track |
| S042 | 1990-02-01 | Normal 180 Day Track |
| S041 | 1989-12-15 | Normal 180 Day Track |
| S040 | 1989-11-30 | Normal 180 Day Track |
| S039 | 1989-11-30 | Normal 180 Day Track |
| S038 | 1989-10-25 | Normal 180 Day Track |
| S037 | 1989-08-22 | Normal 180 Day Track |
| S036 | ||
| S035 | ||
| S034 | 1989-01-31 | Normal 180 Day Track |
| S033 | 1988-12-19 | Normal 180 Day Track |
| S032 | 1988-10-27 | 30-Day Supplement |
| S031 | 1988-08-29 | Normal 180 Day Track |
| S030 | 1988-05-23 | Normal 180 Day Track |
| S029 | 1988-03-09 | Normal 180 Day Track |
| S028 | 1988-01-11 | Normal 180 Day Track |
| S027 | 1987-12-15 | Normal 180 Day Track |
| S026 | 1987-11-19 | Normal 180 Day Track |
| S025 | 1987-11-02 | Normal 180 Day Track |
| S024 | 1987-10-13 | Normal 180 Day Track |
| S023 | 1987-10-19 | Normal 180 Day Track |
| S022 | 1987-08-17 | Normal 180 Day Track |
| S021 | 1987-07-20 | Normal 180 Day Track |
| S020 | 1987-06-23 | Normal 180 Day Track |
| S019 | 1987-04-30 | Normal 180 Day Track |
| S018 | 1986-11-19 | Normal 180 Day Track |
| S017 | 1986-03-28 | Panel Track |
| S016 | 1985-05-02 | |
| S015 | 1985-05-02 | |
| S014 | 1985-04-22 | |
| S013 | 1985-04-11 | |
| S012 | 1984-10-01 | |
| S011 | ||
| S010 | 1984-05-31 | |
| S009 | ||
| S008 | 1983-12-02 | |
| S007 | ||
| S006 | 1983-09-02 | |
| S005 | 1983-08-08 | |
| S004 | 1983-06-09 | |
| S003 | 1983-05-31 | |
| S002 | 1983-04-08 | |
| S001 |