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 | CELUSOFT (POLYMACON) LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | SALVATORI OPHTHALMICS MFG. CORP. |
| Date Received | 1982-12-27 |
| Decision Date | 1983-03-15 |
| PMA | P820005 |
| Supplement | S003 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SALVATORI OPHTHALMICS MFG. CORP. 6416 Parkland Dr. sarasota, FL 34243 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820005 | Original Filing | |
| S007 | 1990-08-02 | Normal 180 Day Track |
| S006 | 1989-12-29 | Normal 180 Day Track |
| S005 | ||
| S004 | 1983-03-04 | |
| S003 | 1982-12-27 | |
| S002 | ||
| S001 | 1982-06-15 |