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 lenses models c440z, u211m, uv91f, uv91f2, u691f, u691f2, c440u, c421f5, and c451f5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
| Device | POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 1996-07-23 |
| Decision Date | 1998-01-29 |
| PMA | P830056 |
| Supplement | S078 |
| 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 | 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 |