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 of the ctl process for the csi(tm) lens from san diego, ca to wesley jessen, inc. , route 173, kilometer 1. 1, el jibaro industrial park, p. O. Box 1980, cidra, puerto rico 00739.
| Device | CSI (CROFILCON A) EXTENDED WEAR SOFT |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1999-09-01 |
| Decision Date | 1999-11-18 |
| PMA | N17987 |
| Supplement | S027 |
| 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 |
|---|---|---|
| N17987 | Original Filing | |
| S028 | 1999-10-27 | Normal 180 Day Track |
| S027 | 1999-09-01 | Normal 180 Day Track |
| S026 | 1999-07-28 | Normal 180 Day Track |
| S025 | ||
| S024 | 1992-08-24 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1989-08-23 | Normal 180 Day Track |
| S020 | 1989-07-24 | Normal 180 Day Track |
| S019 | 1988-12-23 | Normal 180 Day Track |
| S018 | 1988-07-11 | Normal 180 Day Track |
| S017 | 1988-05-13 | Normal 180 Day Track |
| S016 | 1987-12-15 | Normal 180 Day Track |
| S015 | 1987-06-02 | 30-Day Supplement |
| S014 | 1987-05-26 | Normal 180 Day Track |
| S013 | 1985-12-10 | |
| S012 | 1985-04-02 | |
| S011 | 1984-09-24 | |
| S010 | 1984-01-25 | |
| S009 | 1983-07-28 | |
| S008 | 1983-03-30 | |
| S007 | 1983-01-17 | |
| S006 | 1981-11-12 | |
| S005 | ||
| S004 | 1980-11-17 | |
| S003 | ||
| S002 | 1979-11-15 | |
| S001 | 1979-09-14 |