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 | DANKER SILICONE LENS (DIMEFOCON-A) |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1989-07-24 |
| Decision Date | 1990-01-23 |
| PMA | P790010 |
| Supplement | S007 |
| Product Code | LPM |
| 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 Pkwy. duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790010 | Original Filing | |
| S007 | 1989-07-24 | Normal 180 Day Track |
| S006 | 1987-09-24 | Normal 180 Day Track |
| S005 | 1984-05-25 | |
| S004 | 1983-06-23 | |
| S003 | ||
| S002 | 1982-12-15 | |
| S001 | 1982-06-25 |