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 the frequency multifocal (methafilcona) soft (hydrophilic) contact lenses for extended wear (clear and tinted). The lenses are indicated for extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2. 00 diopters or less that does not interfere with visual acuity.
| Device | FREQUENCY MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND TINTED) |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2001-06-01 |
| Decision Date | 2001-07-25 |
| PMA | P850079 |
| Supplement | S038 |
| 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 | COOPERVISION, INC. 370 Woodcliff Drive suite 200 fairport, NY 14450-0000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850079 | Original Filing | |
| S089 | 2020-08-03 | 30-day Notice |
| S088 | 2020-06-29 | 30-day Notice |
| S087 | 2020-03-24 | 30-day Notice |
| S086 | 2020-02-13 | 30-day Notice |
| S085 | 2019-10-15 | 30-day Notice |
| S084 | 2019-08-09 | 30-day Notice |
| S083 | 2019-05-13 | 30-day Notice |
| S082 | 2019-04-16 | 30-day Notice |
| S081 | ||
| S080 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S079 | 2018-06-07 | 30-day Notice |
| S078 | 2018-02-14 | 30-day Notice |
| S077 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S076 | 2017-10-26 | 30-day Notice |
| S075 | 2017-09-20 | 30-day Notice |
| S074 | 2017-07-19 | 30-day Notice |
| S073 | 2017-01-30 | 30-day Notice |
| S072 | 2017-01-19 | 30-day Notice |
| S071 | 2016-12-22 | 30-day Notice |
| S070 | 2016-02-12 | 30-day Notice |
| S069 | 2015-10-19 | 30-day Notice |
| S068 | 2015-09-04 | 30-day Notice |
| S067 | 2014-08-08 | 30-day Notice |
| S066 | ||
| S065 | 2013-08-19 | 30-day Notice |
| S064 | 2012-12-19 | 30-day Notice |
| S063 | 2012-12-10 | 135 Review Track For 30-day Notice |
| S062 | 2012-11-09 | 30-day Notice |
| S061 | 2012-10-24 | 30-day Notice |
| S060 | 2012-10-23 | 30-day Notice |
| S059 | 2012-10-09 | 30-day Notice |
| S058 | 2012-10-09 | 30-day Notice |
| S057 | 2012-09-20 | 30-day Notice |
| S056 | 2012-08-24 | 30-day Notice |
| S055 | 2012-08-20 | 30-day Notice |
| S054 | 2012-08-20 | 30-day Notice |
| S053 | 2012-06-12 | 30-day Notice |
| S052 | 2012-04-10 | 30-day Notice |
| S051 | 2011-11-01 | 30-day Notice |
| S050 | 2011-08-16 | Normal 180 Day Track No User Fee |
| S049 | 2011-01-28 | 30-day Notice |
| S048 | 2010-02-16 | 135 Review Track For 30-day Notice |
| S047 | 2009-12-28 | Normal 180 Day Track No User Fee |
| S046 | 2009-10-13 | 135 Review Track For 30-day Notice |
| S045 | 2009-03-18 | 30-day Notice |
| S044 | ||
| S043 | 2008-05-27 | 30-day Notice |
| S042 | 2005-05-03 | Normal 180 Day Track No User Fee |
| S041 | 2002-08-20 | Normal 180 Day Track |
| S040 | 2002-05-15 | Normal 180 Day Track |
| S039 | 2001-12-06 | Normal 180 Day Track |
| S038 | 2001-06-01 | Normal 180 Day Track |
| S037 | 2000-08-16 | Normal 180 Day Track |
| S036 | 2000-03-06 | 30-day Notice |
| S035 | ||
| S034 | 2000-02-02 | Normal 180 Day Track |
| S033 | ||
| S032 | 1999-09-28 | Normal 180 Day Track |
| S031 | 1999-04-14 | Normal 180 Day Track |
| S030 | 1999-03-11 | Normal 180 Day Track |
| S029 | 1998-01-20 | Normal 180 Day Track |
| S028 | 1996-07-12 | Normal 180 Day Track |
| S027 | 1996-06-19 | Normal 180 Day Track |
| S026 | 1995-03-31 | 30-Day Supplement |
| S025 | 1994-05-04 | Special (immediate Track) |
| S024 | 1993-02-25 | Normal 180 Day Track |
| S023 | ||
| S022 | ||
| S021 | 1991-12-11 | Normal 180 Day Track |
| S020 | 1991-11-04 | Normal 180 Day Track |
| S019 | 1991-07-15 | Normal 180 Day Track |
| S018 | 1990-12-10 | Normal 180 Day Track |
| S017 | 1990-12-07 | Normal 180 Day Track |
| S016 | 1990-01-31 | Normal 180 Day Track |
| S015 | 1990-01-17 | Normal 180 Day Track |
| S014 | 1989-06-12 | Normal 180 Day Track |
| S013 | 1989-02-06 | Normal 180 Day Track |
| S012 | 1988-12-09 | Normal 180 Day Track |
| S011 | 1988-09-19 | Normal 180 Day Track |
| S010 | 1988-04-08 | Normal 180 Day Track |
| S009 | 1987-11-12 | Normal 180 Day Track |
| S008 | 1987-11-04 | Special (immediate Track) |
| S007 | 1987-03-03 | 30-Day Supplement |
| S006 | ||
| S005 | 1986-09-12 | Normal 180 Day Track |
| S004 | 1986-07-28 | Normal 180 Day Track |
| S003 | 1986-07-18 | Normal 180 Day Track |
| S002 | 1986-07-18 | Normal 180 Day Track |
| S001 | 1985-10-02 |