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

• Device: HYDRASOFT (METHAFILCON B) CONTACT LENS
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: COOPERVISION, INC.
• Date Received: 1985-10-30
• Decision Date: 1986-01-31
• Notice Date: 1986-03-28
• PMA: P850079
• Supplement: S
• Product Code: LPM
• Docket Number: 86M-0110
• Advisory Committee: Ophthalmic
• Expedited Review: No
• Combination Product: No
• Applicant Address: COOPERVISION, INC. 370 Woodcliff Drive suite 200 fairport, NY 14450-0000

Supplemental Filings

Supplement Number	Date	Supplement Type
P850079		Original 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