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 a manufacturing site transfer to wesley jessen inc. , cidra, puerto rico.
| Device | GENTLETOUCH (NETRAFILCON A)EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 2000-02-28 |
| Decision Date | 2000-05-02 |
| PMA | P890012 |
| Supplement | S005 |
| 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 |
|---|---|---|
| P890012 | Original Filing | |
| S005 | 2000-02-28 | Normal 180 Day Track |
| S004 | 1999-03-25 | Normal 180 Day Track |
| S003 | 1994-10-06 | 30-Day Supplement |
| S002 | 1990-12-28 | Normal 180 Day Track |
| S001 | 1989-09-25 | Normal 180 Day Track |