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 | STYLE UV40 POSTERIOR CHAMBER LENS |
Generic Name | Intraocular Lens |
Applicant | CARL ZEISS MEDITEC AG |
Date Received | 1987-08-11 |
Decision Date | 1988-01-13 |
PMA | P830056 |
Supplement | S029 |
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 | CARL ZEISS MEDITEC AG 5160 Hacienda Drive dublin, CA 94568 |
Supplement Number | Date | Supplement Type |
---|---|---|
P830056 | Original Filing | |
S079 | 1998-11-12 | Normal 180 Day Track |
S078 | 1996-07-23 | Normal 180 Day Track |
S077 | 1996-05-31 | Normal 180 Day Track |
S076 | ||
S075 | 1994-06-17 | Normal 180 Day Track |
S074 | 1993-02-19 | Normal 180 Day Track |
S073 | ||
S072 | 1990-09-26 | Normal 180 Day Track |
S071 | 1990-09-26 | Normal 180 Day Track |
S070 | 1990-09-19 | Normal 180 Day Track |
S069 | 1990-09-17 | Normal 180 Day Track |
S068 | ||
S067 | ||
S066 | ||
S065 | ||
S064 | ||
S063 | ||
S062 | ||
S061 | 1989-02-24 | Normal 180 Day Track |
S060 | 1989-01-10 | Normal 180 Day Track |
S059 | ||
S058 | ||
S057 | ||
S056 | ||
S055 | 1988-12-15 | Normal 180 Day Track |
S054 | ||
S053 | ||
S052 | ||
S051 | ||
S050 | 1988-11-22 | Normal 180 Day Track |
S049 | ||
S048 | ||
S047 | 1988-10-04 | Normal 180 Day Track |
S046 | 1988-09-29 | Normal 180 Day Track |
S045 | ||
S044 | 1988-09-26 | Normal 180 Day Track |
S043 | 1988-09-21 | Normal 180 Day Track |
S042 | 1988-09-13 | Normal 180 Day Track |
S041 | 1988-08-25 | Normal 180 Day Track |
S040 | 1988-07-26 | Normal 180 Day Track |
S039 | 1988-05-03 | Normal 180 Day Track |
S038 | ||
S037 | ||
S036 | 1988-03-31 | Normal 180 Day Track |
S035 | 1988-01-07 | Normal 180 Day Track |
S034 | ||
S033 | 1987-12-24 | Normal 180 Day Track |
S032 | 1987-10-26 | Normal 180 Day Track |
S031 | 1987-09-11 | Normal 180 Day Track |
S030 | 1987-08-17 | Normal 180 Day Track |
S029 | 1987-08-11 | Normal 180 Day Track |
S028 | 1987-07-21 | Normal 180 Day Track |
S027 | 1987-03-24 | Normal 180 Day Track |
S026 | 1987-03-04 | Normal 180 Day Track |
S025 | 1987-02-19 | Normal 180 Day Track |
S024 | 1987-01-16 | Normal 180 Day Track |
S023 | 1986-12-05 | Normal 180 Day Track |
S022 | 1986-10-28 | Normal 180 Day Track |
S021 | 1986-11-12 | Normal 180 Day Track |
S020 | 1986-11-12 | Normal 180 Day Track |
S019 | 1986-11-12 | Normal 180 Day Track |
S018 | 1986-11-12 | Normal 180 Day Track |
S017 | 1986-11-07 | Normal 180 Day Track |
S016 | 1986-10-31 | Normal 180 Day Track |
S015 | 1986-10-22 | Normal 180 Day Track |
S014 | 1986-08-25 | Normal 180 Day Track |
S013 | 1986-08-06 | Normal 180 Day Track |
S012 | 1986-08-06 | Normal 180 Day Track |
S011 | 1986-07-21 | Normal 180 Day Track |
S010 | ||
S009 | 1986-06-30 | Normal 180 Day Track |
S008 | 1986-06-09 | Normal 180 Day Track |
S007 | 1986-04-25 | |
S006 | 1986-04-25 | |
S005 | 1986-04-25 | |
S004 | 1986-04-25 | |
S003 | 1986-01-30 | |
S002 | 1986-02-24 | |
S001 | 1986-03-28 |