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.
Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing biological indicators.
| Device | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | UNILENS CORPORATION USA |
| Date Received | 1998-06-25 |
| Decision Date | 1998-07-09 |
| PMA | P960039 |
| Supplement | S001 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |
|---|---|---|
| P960039 | Original Filing | |
| S003 | 2007-12-31 | 135 Review Track For 30-day Notice |
| S002 | 2001-01-29 | Normal 180 Day Track |
| S001 | 1998-06-25 | 30-day Notice |