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 an alternate molded lens manufacturing process for a multifocal lens design. The device, as modified, will be marketed under the trade name sunsoft multiples(tm) and is indicated for dialy wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3. 00 diopters (d) of add and who exhibit refractive astigmatism of no more than 1. 50 d that does not interfere with visual acuity. The lens ranges in spherical power from -20. 00d to +10. 00 d.
| 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 | 1997-04-16 |
| Decision Date | 1997-05-19 |
| PMA | P850077 |
| Supplement | S023 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |