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. The device, as modified, will be marketed under the trade name sunsoft multiples(tm) and are indicated as follows: 1)multiples toric lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in not-aphakic person with nondiseased eyes that are myopic or hyperopic and ahve refractive astigmatism not exceeding 7. 00 diopters (d). 2) multiples spherical lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are myopic or hyperopic. The lenses may be worn by persons who exhibit refractive astigmatism of 1. 50 d or less that does not interfere with visual acuity. The lenses range in power from -20. 00 d to +10. 00 d. 3) multiples aphakic lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lenses are indicated for the correction of visual acuity in aphakic persons with nondiseased eyes that are hyperopic. The lenses may be worn by persons who exhibit refractive astigmatism of 1. 50 d or less that does not interfere with visual acuity. The lenses range in power from +10. 50 d to +20. 00 d.
| Device | SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPER VISION, INC. |
| Date Received | 1996-11-22 |
| Decision Date | 1997-03-10 |
| PMA | P850077 |
| Supplement | S022 |
| Product Code | LPL |
| 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 |