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 | FLUOROCON TM-60 |
| Classification Name | Lens, Contact (polymethylmethacrylate) |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1989-09-29 |
| Decision Date | 1990-12-28 |
| Notice Date | 1990-12-28 |
| PMA | P890020 |
| Supplement | S001 |
| Product Code | HPX |
| Docket Number | 91M-0013 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890020 | Original Filing | |
| S002 | 1990-07-16 | Normal 180 Day Track |
| S001 | 1989-09-29 | Normal 180 Day Track |