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.
Approval for the manufacturing facility located at unilens corporation, usa, largo, florida.
| Device | SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | UNILENS CORPORATION USA |
| Date Received | 2001-01-29 |
| Decision Date | 2002-01-03 |
| PMA | P960039 |
| Supplement | S002 |
| Product Code | LPM |
| 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 |
|---|---|---|
| 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 |