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 (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1990-07-16 |
| Decision Date | 1990-09-18 |
| PMA | P890020 |
| Supplement | S002 |
| Product Code | MWL |
| 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 | 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 |