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 a change in the test specifications of the saline solutions that are manufactured at the coopervision caribbean corporation manufacturing facility in juana diaz, puerto rico and used in the packaging of ocufilcon d soft (hydrophilic) contact lenses in blister containers.
Device | ocufilcon D Sift (Hydrophilie) Contact Lenses |
Classification Name | Lenses, Soft Contact, Extended Wear |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | THE COOPER COMPANIES |
Date Received | 2017-08-04 |
Decision Date | 2017-12-19 |
PMA | P890023 |
Supplement | S028 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Real-time Process |
Supplement Reason | Change Design/components/specifications/material |
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 |