VISTAKON (etafilcon A) Brand Contact Lenses

FDA Premarket Approval N18033 S107

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

The addition of an in-process control point during the manufacture of vistakon (senofilcon a) and (etafilcon a) brand contact lenses

DeviceVISTAKON (etafilcon A) Brand Contact Lenses
Generic NameLenses, Soft Contact, Extended Wear
ApplicantVISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.
Date Received2020-05-05
Decision Date2020-06-01
PMAN18033
SupplementS107
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 Centurion Pkwy. jacksonville, FL 32256

Supplemental Filings

Supplement NumberDateSupplement Type
N18033Original Filing
S107 2020-05-05 30-day Notice
S106
S105 2019-05-14 30-day Notice
S104 2019-05-03 30-day Notice
S103 2019-04-25 30-day Notice
S102 2019-03-28 30-day Notice
S101
S100 2018-09-04 30-day Notice
S099 2018-06-18 30-day Notice
S098 2018-04-30 30-day Notice
S097 2018-02-12 30-day Notice
S096 2017-10-17 30-day Notice
S095 2017-09-27 30-day Notice
S094 2017-08-01 30-day Notice
S093 2017-07-03 30-day Notice
S092 2017-05-24 30-day Notice
S091 2017-04-14 30-day Notice
S090 2017-04-10 30-day Notice
S089 2017-03-27 30-day Notice
S088 2017-02-06 30-day Notice
S087 2017-01-27 30-day Notice
S086 2017-01-17 30-day Notice
S085 2016-12-20 30-day Notice
S084 2016-11-01 30-day Notice
S083 2016-07-15 30-day Notice
S082 2016-07-13 Special (immediate Track)
S081 2016-04-11 30-day Notice
S080 2016-02-08 30-day Notice
S079 2015-09-21 30-day Notice
S078
S077 2015-04-09 30-day Notice
S076 2015-04-03 30-day Notice
S075 2014-12-23 30-day Notice
S074 2014-07-15 30-day Notice
S073 2013-07-26 30-day Notice
S072 2013-04-02 30-day Notice
S071
S070 2013-02-13 30-day Notice
S069 2013-02-05 30-day Notice
S068 2013-01-28 30-day Notice
S067 2012-11-13 30-day Notice
S066 2012-07-06 30-day Notice
S065 2012-04-12 30-day Notice
S064 2012-02-28 30-day Notice
S063 2011-11-23 30-day Notice
S062 2011-11-07 30-day Notice
S061 2011-09-19 135 Review Track For 30-day Notice
S060 2011-08-15 30-day Notice
S059 2011-05-23 30-day Notice
S058 2011-05-17 30-day Notice
S057 2011-05-16 30-day Notice
S056 2011-05-12 30-day Notice
S055 2011-04-22 30-day Notice
S054 2011-03-10 30-day Notice
S053 2011-01-18 30-day Notice
S052 2011-01-18 30-day Notice
S051
S050 2010-10-08 30-day Notice
S049 2010-10-01 30-day Notice
S048 2010-09-29 135 Review Track For 30-day Notice
S047 2010-06-28 30-day Notice
S046 2010-04-02 30-day Notice
S045 2010-03-10 135 Review Track For 30-day Notice
S044 2010-03-08 135 Review Track For 30-day Notice
S043 2009-09-23 30-day Notice
S042 2009-06-22 Real-time Process
S041 2009-04-20 30-day Notice
S040 2006-09-05 Real-time Process
S039 2003-12-22 Real-time Process
S038 2002-12-16 Real-time Process
S037 2002-02-19 Special (immediate Track)
S036 2001-06-29 Real-time Process
S035 2001-01-29 Normal 180 Day Track
S034 2000-11-03 Normal 180 Day Track
S033 1999-04-01 Real-time Process
S032 1999-03-01 Real-time Process
S031 1997-07-03 Real-time Process
S030 1997-05-02 Real-time Process
S029 1996-07-18 Normal 180 Day Track
S028 1996-02-06 Normal 180 Day Track
S027 1993-05-14 Normal 180 Day Track
S026 1992-10-16 Normal 180 Day Track
S025 1990-09-21 Normal 180 Day Track
S024 1990-06-05 Normal 180 Day Track
S023
S022 1989-07-20 Normal 180 Day Track
S021 1989-07-20 Normal 180 Day Track
S020 1989-07-20 Normal 180 Day Track
S019 1988-03-14 Normal 180 Day Track
S018 1987-09-15 Special (immediate Track)
S017 1987-09-16 Special (immediate Track)
S016 1987-05-18 Normal 180 Day Track
S015 1986-07-23 Normal 180 Day Track
S014 1986-03-26
S013 1985-09-11
S012
S011 1985-02-25
S010 1984-12-10
S009 1983-12-21
S008 1983-07-15
S007 1983-03-24
S006 1982-12-27
S005 1982-07-07
S004 1982-04-08
S003 1981-03-05
S002
S001 1979-08-28

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