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 | EXCELENS (ATLAFILCON A) CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1989-12-05 |
| Decision Date | 1990-03-06 |
| PMA | P890029 |
| Supplement | S001 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890029 | Original Filing | |
| S003 | 1990-12-31 | Normal 180 Day Track |
| S002 | 1990-01-29 | Normal 180 Day Track |
| S001 | 1989-12-05 | Normal 180 Day Track |