HYDRASOFT (METHAFILCON B) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P850079

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceHYDRASOFT (METHAFILCON B) CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received1985-10-30
Decision Date1986-01-31
Notice Date1986-03-28
PMAP850079
SupplementS
Product CodeLPM
Docket Number86M-0110
Advisory CommitteeOphthalmic
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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