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.
Use of fully automated manufacturing equipment in the production of methafilcon a contact lenses.
| Device | FREQUENCY 55, FREQUENCY 55 ASPHERIC, FREQUENCY XCEL TORIC, FREQUENCY 55 TORIC |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2012-10-24 |
| Decision Date | 2012-11-20 |
| PMA | P850079 |
| Supplement | S061 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |