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.
Approval for the manufacturing facility located at wesley jessen, inc. , cidra, puerto rico.
| Device | CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1999-12-23 |
| Decision Date | 2000-09-18 |
| PMA | P850057 |
| Supplement | S006 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |