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.
Appoval for consolidated and reformateed labeling for the eclipse, sunflex, toric 15. 0, revolution, sportsoft, aphakic, and multifocal lenses. The devices, as modified, will be marketed under the trade names eclipse(r) (methafilcon a) soft (hydrophilic) contact lenses, toric 15. 0(r) (methafilcon a) soft (hydrophilic) contact lenses, sunflex(r) (methafilcon a) soft (hydrophilic) contact lens, revolution (tm) (methafilcon a) soft (hydrophilic) contact lenses, sportsoft(r) (methafilcon a) soft (hydrophilic) contact lenses, sunsoft (methafilcon a) soft (hydrophilic) aphakic extended wear contact lenses, sunsoft (methafilcon a) soft (hydrophilic) aphakic extended wear contact lens, and sunsoft multifocal(r) (methafilcon a) soft (hydrophilic) contact lenses. The indications and shelf-life for these devices remain unchanged from that previously approved.
| Device | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPER VISION, INC. |
| Date Received | 1997-05-07 |
| Decision Date | 1997-06-20 |
| PMA | P850077 |
| Supplement | S024 |
| 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 |