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 | FLUOREX (TM) 600 (FLURSILFOCON A) |
| Classification Name | Lens, Contact (other Material) - Daily |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | G.T. LABORATORIES, INC. |
| Date Received | 1989-05-17 |
| Decision Date | 1989-11-20 |
| PMA | P880001 |
| Supplement | S014 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | G.T. LABORATORIES, INC. 111 No. Wabash Ave. chicago, IL 60602 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880001 | Original Filing | |
| S040 | 1993-10-29 | Normal 180 Day Track |
| S039 | 1993-08-24 | Normal 180 Day Track |
| S038 | 1993-04-19 | Normal 180 Day Track |
| S037 | 1993-02-05 | Normal 180 Day Track |
| S036 | 1992-08-19 | Normal 180 Day Track |
| S035 | 1992-06-01 | Normal 180 Day Track |
| S034 | 1992-04-03 | Normal 180 Day Track |
| S033 | 1992-03-12 | Normal 180 Day Track |
| S032 | 1992-01-10 | Normal 180 Day Track |
| S031 | 1991-11-25 | Normal 180 Day Track |
| S030 | 1991-07-29 | Normal 180 Day Track |
| S029 | 1990-10-22 | Normal 180 Day Track |
| S028 | 1990-09-06 | Normal 180 Day Track |
| S027 | 1990-07-23 | 30-Day Supplement |
| S026 | 1990-05-31 | 30-Day Supplement |
| S025 | 1990-03-15 | Normal 180 Day Track |
| S024 | 1989-11-13 | Normal 180 Day Track |
| S023 | 1989-10-12 | Normal 180 Day Track |
| S022 | ||
| S021 | 1989-09-05 | Normal 180 Day Track |
| S020 | 1989-08-08 | Normal 180 Day Track |
| S019 | 1989-07-21 | Normal 180 Day Track |
| S018 | 1989-07-19 | Normal 180 Day Track |
| S017 | 1989-06-23 | Normal 180 Day Track |
| S016 | 1989-06-19 | Normal 180 Day Track |
| S015 | 1989-05-22 | Normal 180 Day Track |
| S014 | 1989-05-17 | Normal 180 Day Track |
| S013 | 1989-04-19 | Normal 180 Day Track |
| S012 | 1989-03-24 | Normal 180 Day Track |
| S011 | 1989-03-01 | Normal 180 Day Track |
| S010 | 1989-02-16 | Normal 180 Day Track |
| S009 | 1989-02-14 | Normal 180 Day Track |
| S008 | 1989-02-08 | Normal 180 Day Track |
| S007 | 1989-01-13 | Normal 180 Day Track |
| S006 | 1988-12-19 | Normal 180 Day Track |
| S005 | 1988-11-23 | Normal 180 Day Track |
| S004 | 1988-11-21 | 30-Day Supplement |
| S003 | 1988-10-18 | Normal 180 Day Track |
| S002 | 1988-10-07 | Normal 180 Day Track |
| S001 | 1988-10-03 | 30-Day Supplement |
| Device ID | PMA | Supp |
|---|---|---|
| B316FLX7000 | P880001 | 028 |
| B316FLX500UV0 | P880001 | 028 |
| B316FLX3000 | P880001 | 028 |