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 for tier a posterior chamber intraocular lens model 777a. This intraocular lens is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.
| Device | MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1997-03-06 |
| Decision Date | 1997-05-28 |
| PMA | P810055 |
| Supplement | S067 |
| 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 |
|---|---|---|
| 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 |