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 (R) (TEFILICON) HYDROPHILIC CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CARE |
| Date Received | 1989-08-01 |
| Decision Date | 1990-01-31 |
| PMA | P810005 |
| Supplement | S024 |
| Product Code | LPL |
| 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 | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810005 | Original Filing | |
| S027 | 1991-05-01 | Normal 180 Day Track |
| S026 | 1991-04-03 | Normal 180 Day Track |
| S025 | 1989-11-02 | Normal 180 Day Track |
| S024 | 1989-08-01 | Normal 180 Day Track |
| S023 | 1989-07-24 | Normal 180 Day Track |
| S022 | 1989-07-17 | Normal 180 Day Track |
| S021 | 1988-05-23 | Normal 180 Day Track |
| S020 | 1988-01-27 | Normal 180 Day Track |
| S019 | ||
| S018 | 1986-05-01 | |
| S017 | 1986-02-20 | |
| S016 | 1986-02-04 | |
| S015 | 1985-07-08 | |
| S014 | 1985-07-02 | |
| S013 | 1985-05-07 | |
| S012 | 1985-01-17 | |
| S011 | 1984-04-26 | |
| S010 | 1984-03-13 | |
| S009 | 1983-12-01 | |
| S008 | ||
| S007 | 1983-04-15 | |
| S006 | 1982-11-22 | |
| S005 | 1982-11-22 | |
| S004 | 1982-10-04 | |
| S003 | 1982-03-26 | |
| S002 | 1981-10-13 | |
| S001 | 1981-10-13 |