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.
| Device | HYDRON HYDROPHILIC CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Daily Wear |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 1987-04-28 |
| Decision Date | 1987-06-16 |
| PMA | P780007 |
| Supplement | S027 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| 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 |
|---|---|---|
| P780007 | Original Filing | |
| S062 | 2019-08-13 | 30-day Notice |
| S061 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S060 | 2018-03-05 | Real-time Process |
| S059 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S058 | 2017-10-24 | 30-day Notice |
| S057 | ||
| S056 | 2017-01-30 | 30-day Notice |
| S055 | 2017-01-08 | 30-day Notice |
| S054 | 2015-07-02 | 30-day Notice |
| S053 | 2013-11-13 | 135 Review Track For 30-day Notice |
| S052 | 2013-11-12 | 30-day Notice |
| S051 | 2013-07-22 | 30-day Notice |
| S050 | ||
| S049 | 2012-01-12 | 30-day Notice |
| S048 | 2012-01-12 | 30-day Notice |
| S047 | 2012-01-12 | 30-day Notice |
| S046 | 2011-09-22 | 30-day Notice |
| S045 | 2011-02-24 | 30-day Notice |
| S044 | 2008-10-23 | 30-day Notice |
| S043 | 2003-01-10 | Normal 180 Day Track No User Fee |
| S042 | 1999-09-17 | Normal 180 Day Track |
| S041 | 1996-02-06 | Normal 180 Day Track |
| S040 | ||
| S039 | 1993-04-15 | Normal 180 Day Track |
| S038 | 1992-05-11 | Normal 180 Day Track |
| S037 | 1991-04-17 | Normal 180 Day Track |
| S036 | 1990-10-31 | Normal 180 Day Track |
| S035 | 1990-08-01 | Normal 180 Day Track |
| S034 | 1989-07-20 | Normal 180 Day Track |
| S033 | 1989-05-09 | Normal 180 Day Track |
| S032 | 1988-10-31 | Normal 180 Day Track |
| S031 | 1988-07-08 | Normal 180 Day Track |
| S030 | ||
| S029 | 1988-02-12 | Normal 180 Day Track |
| S028 | 1988-01-21 | Panel Track |
| S027 | 1987-04-28 | 30-Day Supplement |
| S026 | 1986-12-29 | Normal 180 Day Track |
| S025 | 1986-10-30 | Normal 180 Day Track |
| S024 | 1986-09-22 | Normal 180 Day Track |
| S023 | 1985-02-25 | |
| S022 | ||
| S021 | ||
| S020 | 1984-11-07 | |
| S019 | 1984-10-11 | |
| S018 | 1984-10-09 | |
| S017 | 1984-09-10 | |
| S016 | 1984-07-27 | |
| S015 | 1984-01-26 | |
| S014 | 1983-09-02 | |
| S013 | ||
| S012 | 1982-04-29 | |
| S011 | ||
| S010 | 1982-04-29 | |
| S009 | 1982-03-09 | |
| S008 | 1981-07-31 | |
| S007 | 1980-11-07 | Normal 180 Day Track |
| S006 | 1980-04-15 | |
| S005 | 1980-02-01 | |
| S004 | 1979-11-19 | |
| S003 | 1979-10-31 | |
| S002 | 1979-10-31 | |
| S001 | 1979-09-27 | Normal 180 Day Track |