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 | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPER VISION, INC. |
| Date Received | 1994-09-27 |
| Decision Date | 1995-05-05 |
| PMA | P850077 |
| Supplement | S020 |
| 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 | COOPER VISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850077 | Original Filing | |
| S024 | 1997-05-07 | Normal 180 Day Track |
| S023 | 1997-04-16 | Normal 180 Day Track |
| S022 | 1996-11-22 | Normal 180 Day Track |
| S021 | 1994-12-19 | Normal 180 Day Track |
| S020 | 1994-09-27 | Normal 180 Day Track |
| S019 | 1994-01-26 | Normal 180 Day Track |
| S018 | 1992-03-06 | Normal 180 Day Track |
| S017 | 1992-02-26 | Normal 180 Day Track |
| S016 | ||
| S015 | 1991-02-21 | Normal 180 Day Track |
| S014 | 1991-01-18 | Normal 180 Day Track |
| S013 | 1990-01-05 | Normal 180 Day Track |
| S012 | 1989-11-09 | Normal 180 Day Track |
| S011 | 1989-07-20 | Normal 180 Day Track |
| S010 | 1988-11-14 | Normal 180 Day Track |
| S009 | ||
| S008 | 1988-04-07 | Normal 180 Day Track |
| S007 | ||
| S006 | 1988-01-19 | Normal 180 Day Track |
| S005 | 1987-11-02 | Normal 180 Day Track |
| S004 | 1986-12-11 | 30-Day Supplement |
| S003 | ||
| S002 | 1986-07-28 | Normal 180 Day Track |
| S001 | 1985-10-02 |