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 | MODEL 304 (ULTRA C-LOOP) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1988-11-10 |
| Decision Date | 1989-10-19 |
| PMA | P860059 |
| Supplement | S023 |
| 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 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860059 | Original Filing | |
| S077 | 1996-04-10 | Normal 180 Day Track |
| S076 | 1996-04-05 | Normal 180 Day Track |
| S075 | 1996-03-06 | Normal 180 Day Track |
| S074 | 1992-09-28 | Normal 180 Day Track |
| S073 | 1992-09-28 | Normal 180 Day Track |
| S072 | ||
| S071 | 1992-08-20 | Normal 180 Day Track |
| S070 | 1992-07-28 | Normal 180 Day Track |
| S069 | 1992-02-25 | Normal 180 Day Track |
| S068 | 1991-11-01 | Normal 180 Day Track |
| S067 | 1991-10-28 | Normal 180 Day Track |
| S066 | 1991-10-07 | Normal 180 Day Track |
| S065 | 1991-06-24 | Normal 180 Day Track |
| S064 | 1991-04-11 | Normal 180 Day Track |
| S063 | 1991-04-04 | Normal 180 Day Track |
| S062 | 1991-01-16 | Normal 180 Day Track |
| S061 | 1991-01-16 | Normal 180 Day Track |
| S060 | ||
| S059 | 1991-01-11 | Normal 180 Day Track |
| S058 | 1991-01-11 | Normal 180 Day Track |
| S057 | ||
| S056 | 1990-11-28 | Normal 180 Day Track |
| S055 | ||
| S054 | 1990-11-16 | Normal 180 Day Track |
| S053 | 1990-11-07 | Normal 180 Day Track |
| S052 | ||
| S051 | 1990-11-07 | Normal 180 Day Track |
| S050 | 1990-10-03 | Normal 180 Day Track |
| S049 | 1989-12-08 | Normal 180 Day Track |
| S048 | 1989-11-22 | Normal 180 Day Track |
| S047 | ||
| S046 | 1989-09-26 | Normal 180 Day Track |
| S045 | 1989-08-23 | Normal 180 Day Track |
| S044 | ||
| S043 | ||
| S042 | ||
| S041 | ||
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | 1989-02-21 | Normal 180 Day Track |
| S036 | 1988-12-23 | Normal 180 Day Track |
| S035 | ||
| S034 | ||
| S033 | 1988-12-20 | Normal 180 Day Track |
| S032 | ||
| S031 | 1988-12-16 | Normal 180 Day Track |
| S030 | ||
| S029 | 1988-11-21 | Normal 180 Day Track |
| S028 | ||
| S027 | ||
| S026 | 1988-11-16 | Normal 180 Day Track |
| S025 | ||
| S024 | ||
| S023 | 1988-11-10 | Normal 180 Day Track |
| S022 | ||
| S021 | 1988-10-31 | Normal 180 Day Track |
| S020 | 1988-10-27 | Normal 180 Day Track |
| S019 | 1988-10-26 | Normal 180 Day Track |
| S018 | ||
| S017 | 1988-10-04 | Normal 180 Day Track |
| S016 | 1988-09-29 | Normal 180 Day Track |
| S015 | 1988-09-26 | Normal 180 Day Track |
| S014 | 1988-09-15 | Normal 180 Day Track |
| S013 | 1988-09-09 | Normal 180 Day Track |
| S012 | ||
| S011 | 1988-08-18 | Normal 180 Day Track |
| S010 | 1988-08-10 | Normal 180 Day Track |
| S009 | 1988-08-03 | Normal 180 Day Track |
| S008 | 1988-05-19 | Normal 180 Day Track |
| S007 | 1988-04-07 | Normal 180 Day Track |
| S006 | 1988-04-07 | Normal 180 Day Track |
| S005 | 1988-03-15 | Normal 180 Day Track |
| S004 | 1988-03-10 | Normal 180 Day Track |
| S003 | 1988-01-05 | Panel Track |
| S002 | 1987-12-24 | Normal 180 Day Track |
| S001 | 1987-11-03 | Normal 180 Day Track |