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 | TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | UNITED CONTACT LENS, INC. |
| Date Received | 1989-08-25 |
| Decision Date | 1990-01-22 |
| PMA | P870079 |
| Supplement | S005 |
| 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 | UNITED CONTACT LENS, INC. 917-134th St. S.w., #a-4 everett, WA 98204 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870079 | Original Filing | |
| S005 | 1989-08-25 | Normal 180 Day Track |
| S004 | ||
| S003 | 1989-08-03 | Normal 180 Day Track |
| S002 | 1988-11-07 | Normal 180 Day Track |
| S001 | 1988-11-04 | Normal 180 Day Track |