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 | AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORPORATION USA |
| Date Received | 1989-10-02 |
| Decision Date | 1990-09-14 |
| Notice Date | 1990-11-02 |
| PMA | P880101 |
| Supplement | S004 |
| Product Code | LPL |
| Docket Number | 90M-0317 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880101 | Original Filing | |
| S006 | 1994-05-03 | 30-Day Supplement |
| S005 | 1991-07-03 | Normal 180 Day Track |
| S004 | 1989-10-02 | Panel Track |
| S003 | 1989-09-18 | Normal 180 Day Track |
| S002 | 1989-09-14 | Normal 180 Day Track |
| S001 |