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 extend the dioptric power range of model 812b to -10d to +40d. The device 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 | 1997-05-14 |
| Decision Date | 1997-10-22 |
| PMA | P810055 |
| Supplement | S068 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |