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 | SOFTSITE (HEFILCON A) CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORPORATION USA |
| Date Received | 1987-04-08 |
| Decision Date | 1987-10-05 |
| PMA | N17793 |
| Supplement | S013 |
| 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 | UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17793 | Original Filing | |
| S014 | 1987-04-08 | Normal 180 Day Track |
| S013 | 1987-04-08 | Normal 180 Day Track |
| S012 | 1986-09-03 | Normal 180 Day Track |
| S011 | 1985-09-16 | |
| S010 | 1985-09-16 | |
| S009 | 1985-08-19 | |
| S008 | 1983-11-04 | |
| S007 | ||
| S006 | 1983-07-11 | |
| S005 | 1982-01-08 | |
| S004 | 1980-11-06 | |
| S003 | 1980-05-28 | |
| S002 | ||
| S001 | 1979-10-22 |