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 | CUSTOMEYES(TM) 45L&55L (BUFILCON A) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1989-07-24 |
| Decision Date | 1990-01-23 |
| PMA | P850057 |
| Supplement | S004 |
| 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 Parkway duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850057 | Original Filing | |
| S006 | 1999-12-23 | Normal 180 Day Track |
| S005 | 1995-05-15 | Normal 180 Day Track |
| S004 | 1989-07-24 | Normal 180 Day Track |
| S003 | 1986-12-23 | Normal 180 Day Track |
| S002 | 1986-12-04 | Normal 180 Day Track |
| S001 | 1986-07-28 | Normal 180 Day Track |