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 | HYDROCURVE |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1994-10-06 |
| Decision Date | 1994-11-09 |
| PMA | N17752 |
| Supplement | S035 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17752 | Original Filing | |
| S038 | 2001-03-30 | Normal 180 Day Track |
| S037 | 1999-12-23 | Normal 180 Day Track |
| S036 | 1995-05-15 | Normal 180 Day Track |
| S035 | 1994-10-06 | 30-Day Supplement |
| S034 | 1989-08-08 | Normal 180 Day Track |
| S033 | 1989-07-24 | Normal 180 Day Track |
| S032 | 1989-05-17 | Normal 180 Day Track |
| S031 | 1987-12-17 | Normal 180 Day Track |
| S030 | 1987-09-15 | Special (immediate Track) |
| S029 | 1987-03-03 | 30-Day Supplement |
| S028 | 1987-01-12 | Normal 180 Day Track |
| S027 | 1987-01-05 | Normal 180 Day Track |
| S026 | 1986-04-29 | |
| S025 | 1985-11-04 | |
| S024 | 1985-05-20 | |
| S023 | 1985-02-04 | |
| S022 | 1985-02-04 | |
| S021 | 1984-09-14 | |
| S020 | 1984-08-24 | |
| S019 | 1983-10-26 | |
| S018 | 1983-10-06 | |
| S017 | 1983-06-24 | |
| S016 | 1983-06-13 | |
| S015 | 1982-07-07 | |
| S014 | 1981-04-14 | |
| S013 | 1981-04-06 | |
| S012 | 1981-04-07 | |
| S011 | ||
| S010 | 1980-11-04 | |
| S009 | 1980-06-06 | |
| S008 | 1980-03-26 | |
| S007 | 1980-02-15 | |
| S006 | 1980-01-08 | |
| S005 | 1979-08-10 | |
| S004 | 1979-08-10 | |
| S003 | 1979-08-03 | |
| S002 | ||
| S001 | 1978-11-16 |