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.
Implementation of the measuring iol quality system for determining optical performance of iols manufactured at the facility.
Device | CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | ADVANCED MEDICAL OPTICS, INC. |
Date Received | 2008-05-29 |
Decision Date | 2008-07-02 |
PMA | P810055 |
Supplement | S072 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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 |