Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear

FDA Premarket Approval P850079 S089

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.

Pre-market Approval Supplement Details

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DeviceHydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received2020-08-03
Decision Date2020-09-01
PMAP850079
SupplementS089
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COOPERVISION, INC. 370 Woodcliff Drive suite 200 fairport, NY 14450-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P850079Original Filing
S089 2020-08-03 30-day Notice
S088 2020-06-29 30-day Notice
S087 2020-03-24 30-day Notice
S086 2020-02-13 30-day Notice
S085 2019-10-15 30-day Notice
S084 2019-08-09 30-day Notice
S083 2019-05-13 30-day Notice
S082 2019-04-16 30-day Notice
S081
S080 2018-08-09 Normal 180 Day Track No User Fee
S079 2018-06-07 30-day Notice
S078 2018-02-14 30-day Notice
S077 2018-01-16 135 Review Track For 30-day Notice
S076 2017-10-26 30-day Notice
S075 2017-09-20 30-day Notice
S074 2017-07-19 30-day Notice
S073 2017-01-30 30-day Notice
S072 2017-01-19 30-day Notice
S071 2016-12-22 30-day Notice
S070 2016-02-12 30-day Notice
S069 2015-10-19 30-day Notice
S068 2015-09-04 30-day Notice
S067 2014-08-08 30-day Notice
S066
S065 2013-08-19 30-day Notice
S064 2012-12-19 30-day Notice
S063 2012-12-10 135 Review Track For 30-day Notice
S062 2012-11-09 30-day Notice
S061 2012-10-24 30-day Notice
S060 2012-10-23 30-day Notice
S059 2012-10-09 30-day Notice
S058 2012-10-09 30-day Notice
S057 2012-09-20 30-day Notice
S056 2012-08-24 30-day Notice
S055 2012-08-20 30-day Notice
S054 2012-08-20 30-day Notice
S053 2012-06-12 30-day Notice
S052 2012-04-10 30-day Notice
S051 2011-11-01 30-day Notice
S050 2011-08-16 Normal 180 Day Track No User Fee
S049 2011-01-28 30-day Notice
S048 2010-02-16 135 Review Track For 30-day Notice
S047 2009-12-28 Normal 180 Day Track No User Fee
S046 2009-10-13 135 Review Track For 30-day Notice
S045 2009-03-18 30-day Notice
S044
S043 2008-05-27 30-day Notice
S042 2005-05-03 Normal 180 Day Track No User Fee
S041 2002-08-20 Normal 180 Day Track
S040 2002-05-15 Normal 180 Day Track
S039 2001-12-06 Normal 180 Day Track
S038 2001-06-01 Normal 180 Day Track
S037 2000-08-16 Normal 180 Day Track
S036 2000-03-06 30-day Notice
S035
S034 2000-02-02 Normal 180 Day Track
S033
S032 1999-09-28 Normal 180 Day Track
S031 1999-04-14 Normal 180 Day Track
S030 1999-03-11 Normal 180 Day Track
S029 1998-01-20 Normal 180 Day Track
S028 1996-07-12 Normal 180 Day Track
S027 1996-06-19 Normal 180 Day Track
S026 1995-03-31 30-Day Supplement
S025 1994-05-04 Special (immediate Track)
S024 1993-02-25 Normal 180 Day Track
S023
S022
S021 1991-12-11 Normal 180 Day Track
S020 1991-11-04 Normal 180 Day Track
S019 1991-07-15 Normal 180 Day Track
S018 1990-12-10 Normal 180 Day Track
S017 1990-12-07 Normal 180 Day Track
S016 1990-01-31 Normal 180 Day Track
S015 1990-01-17 Normal 180 Day Track
S014 1989-06-12 Normal 180 Day Track
S013 1989-02-06 Normal 180 Day Track
S012 1988-12-09 Normal 180 Day Track
S011 1988-09-19 Normal 180 Day Track
S010 1988-04-08 Normal 180 Day Track
S009 1987-11-12 Normal 180 Day Track
S008 1987-11-04 Special (immediate Track)
S007 1987-03-03 30-Day Supplement
S006
S005 1986-09-12 Normal 180 Day Track
S004 1986-07-28 Normal 180 Day Track
S003 1986-07-18 Normal 180 Day Track
S002 1986-07-18 Normal 180 Day Track
S001 1985-10-02

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