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 reformatting the package insert, professional fitting and information guide, and patient instructions. The modified labeling does not result in changes in the indications for use for the devices
| Device | HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 1996-07-12 |
| Decision Date | 1996-08-01 |
| PMA | P850079 |
| Supplement | S028 |
| Product Code | LPL |
| 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 |