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 models c420p, c540u, c445f, c840u, u240f0, c540mc, u211f, and u241fo posterior chamber intraocular lenses as tier a modifications of clinically studied partent lenses
| Device | POSTERIOR CHAMBER INTROCULAR LENSES |
| Generic Name | Intraocular Lens |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 1994-06-17 |
| Decision Date | 1996-04-02 |
| PMA | P830056 |
| Supplement | S075 |
| 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 |