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 II (POLYMACON) |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | PREMIER CONTACT LENS |
| Date Received | 1994-01-26 |
| Decision Date | 1994-03-01 |
| PMA | P830006 |
| Supplement | S007 |
| 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 | PREMIER CONTACT LENS 201 Fourth Avenue North nashville, TN 37219-2040 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830006 | Original Filing | |
| S007 | 1994-01-26 | Normal 180 Day Track |
| S006 | 1992-02-18 | Normal 180 Day Track |
| S005 | 1990-04-18 | Normal 180 Day Track |
| S004 | 1989-10-26 | Normal 180 Day Track |
| S003 | 1986-06-17 | Normal 180 Day Track |
| S002 | 1986-06-10 | Normal 180 Day Track |
| S001 | 1983-12-13 |