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 | SOFTACT(TM) (DELTAFILCON A) |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | PREMIER CONTACT LENS |
| Date Received | 1984-11-30 |
| Decision Date | 1985-05-20 |
| PMA | P800070 |
| Supplement | S004 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PREMIER CONTACT LENS 201 Fourth Avenue North nashville, TN 37219-2040 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800070 | Original Filing | |
| S004 | 1984-11-30 | |
| S003 | 1983-12-13 | |
| S002 | 1982-12-16 | |
| S001 | 1981-12-14 |