HYDRASOFT (METHAFILCON A) CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P850079 S015

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

• Device: HYDRASOFT (METHAFILCON A) CONTACT LENS
• Classification Name: Lenses, Soft Contact, Daily Wear
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: COOPERVISION, INC.
• Date Received: 1990-01-17
• Decision Date: 1990-12-10
• PMA: P850079
• Supplement: S015
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• 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