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 addition of a new private label brand name sofmed toric weeklies.
| Device | Sofmed Toric Weeklies |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | THE COOPER COMPANIES |
| Date Received | 2016-04-13 |
| Decision Date | 2016-09-22 |
| PMA | P890023 |
| Supplement | S025 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THE COOPER COMPANIES 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890023 | Original Filing | |
| S049 | 2022-08-29 | 30-day Notice |
| S048 | 2022-04-26 | 30-day Notice |
| S047 | 2020-09-25 | 30-day Notice |
| S046 | ||
| S045 | 2020-08-24 | 30-day Notice |
| S044 | 2020-08-20 | 30-day Notice |
| S043 | 2020-08-03 | 30-day Notice |
| S042 | 2020-01-15 | 30-day Notice |
| S041 | ||
| S040 | 2019-12-03 | 30-day Notice |
| S039 | 2019-10-15 | 30-day Notice |
| S038 | 2019-08-13 | 30-day Notice |
| S037 | 2019-02-26 | 30-day Notice |
| S036 | 2019-02-08 | 30-day Notice |
| S035 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S034 | 2018-06-18 | Real-time Process |
| S033 | 2018-06-15 | Real-time Process |
| S032 | 2018-04-05 | Normal 180 Day Track No User Fee |
| S031 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S030 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S029 | 2017-10-24 | 30-day Notice |
| S028 | 2017-08-04 | Real-time Process |
| S027 | 2017-01-30 | 30-day Notice |
| S026 | 2017-01-08 | 30-day Notice |
| S025 | 2016-04-13 | Normal 180 Day Track No User Fee |
| S024 | 2015-12-22 | 30-day Notice |
| S023 | 2015-07-02 | 30-day Notice |
| S022 | 2014-09-08 | Normal 180 Day Track No User Fee |
| S021 | 2013-11-13 | 135 Review Track For 30-day Notice |
| S020 | 2013-11-12 | 30-day Notice |
| S019 | 2013-07-22 | 30-day Notice |
| S018 | 2011-11-01 | 30-day Notice |
| S017 | 2010-04-26 | 135 Review Track For 30-day Notice |
| S016 | 2004-08-18 | Real-time Process |
| S015 | 2004-07-02 | Normal 180 Day Track No User Fee |
| S014 | 2003-12-22 | Normal 180 Day Track No User Fee |
| S013 | 2002-01-18 | Normal 180 Day Track |
| S012 | ||
| S011 | 2001-07-20 | Normal 180 Day Track |
| S010 | ||
| S009 | 1999-09-17 | Normal 180 Day Track |
| S008 | 1999-07-29 | 30-day Notice |
| S007 | 1999-04-20 | Real-time Process |
| S006 | 1996-02-13 | Normal 180 Day Track |
| S005 | 1995-10-23 | Normal 180 Day Track |
| S004 | 1995-10-02 | Normal 180 Day Track |
| S003 | 1995-09-29 | Normal 180 Day Track |
| S002 | 1993-05-24 | Normal 180 Day Track |
| S001 | 1990-10-31 | Normal 180 Day Track |