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 cast molding method for the manufacture of the ocufilcon d 55% hydrophilic contact lens for extended wear at the company's facility located at sant isabel industrial park (formally known as felicia ward industrial park); highway 538, km 0. 7, puerto rico 00757.
Device | H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES FOR EXTENDED WEAR |
Classification Name | Lenses, Soft Contact, Extended Wear |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | THE COOPER COMPANIES |
Date Received | 1995-10-23 |
Decision Date | 1997-05-06 |
PMA | P890023 |
Supplement | S005 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
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 |