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 | TINTED TETRAFILCON A CONTACT LENSES |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1987-08-14 |
| Decision Date | 1987-10-27 |
| PMA | P840071 |
| Supplement | S001 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840071 | Original Filing | |
| S001 | 1987-08-14 | Normal 180 Day Track |