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 | WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1981-09-14 |
| Decision Date | 1982-12-02 |
| PMA | P800011 |
| Supplement | S004 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800011 | Original Filing | |
| S010 | 1989-10-24 | Normal 180 Day Track |
| S009 | 1988-04-14 | Normal 180 Day Track |
| S008 | 1987-12-30 | Normal 180 Day Track |
| S007 | 1985-10-30 | |
| S006 | 1984-01-30 | |
| S005 | 1982-05-27 | |
| S004 | 1981-09-14 | |
| S003 | ||
| S002 | 1980-10-27 | |
| S001 |