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.
Minor modification in the sterilization cycle parameters for ocufilcon d and polymacon extended wear lenses.
| Device | Polymacon Soft (Hydrophilic) Extended Wear Contact Lenses |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2017-10-24 |
| Decision Date | 2017-11-22 |
| PMA | P780007 |
| Supplement | S058 |
| 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 |
|---|---|---|
| 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 |