VISTAKON (senofilcon A)Brand Contact Lenses

FDA Premarket Approval P040045 S114

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 (senofilcon A)Brand Contact Lenses
Generic NameLenses, Soft Contact, Extended Wear
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
Date Received2020-05-05
Decision Date2020-06-01
PMAP040045
SupplementS114
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR 7500 Centurion Parkway suite 100 - Erca jacksonville, FL 32256

Supplemental Filings

Supplement NumberDateSupplement Type
P040045Original Filing
S115 2020-05-19 30-day Notice
S114 2020-05-05 30-day Notice
S113
S112 2019-11-25 30-day Notice
S111
S110 2019-08-30 30-day Notice
S109 2019-05-24 30-day Notice
S108 2019-04-25 30-day Notice
S107 2019-04-25 30-day Notice
S106 2019-04-03 30-day Notice
S105 2019-03-28 30-day Notice
S104 2018-12-21 30-day Notice
S103 2018-12-21 30-day Notice
S102 2018-10-30 30-day Notice
S101 2018-09-04 30-day Notice
S100 2018-07-03 30-day Notice
S099 2018-06-08 30-day Notice
S098 2018-05-25 30-day Notice
S097 2018-04-05 30-day Notice
S096 2018-03-07 30-day Notice
S095 2018-02-16 30-day Notice
S094 2018-02-12 30-day Notice
S093 2018-01-25 30-day Notice
S092 2018-01-17 30-day Notice
S091 2017-11-29 30-day Notice
S090 2017-11-21 30-day Notice
S089 2017-11-13 30-day Notice
S088 2017-11-06 30-day Notice
S087 2017-10-20 30-day Notice
S086 2017-10-17 30-day Notice
S085 2017-10-12 30-day Notice
S084 2017-09-27 30-day Notice
S083 2017-09-27 30-day Notice
S082 2017-08-16 30-day Notice
S081 2017-08-11 30-day Notice
S080 2017-08-01 30-day Notice
S079 2017-07-25 30-day Notice
S078 2017-07-18 30-day Notice
S077 2017-07-03 30-day Notice
S076 2017-05-24 30-day Notice
S075 2017-05-24 30-day Notice
S074 2017-05-24 30-day Notice
S073 2017-05-24 30-day Notice
S072 2017-05-24 30-day Notice
S071 2017-04-14 30-day Notice
S070 2017-04-10 30-day Notice
S069 2017-03-27 30-day Notice
S068 2017-01-27 30-day Notice
S067 2017-01-27 30-day Notice
S066 2017-01-24 30-day Notice
S065 2017-01-17 30-day Notice
S064 2016-12-20 30-day Notice
S063 2016-12-14 30-day Notice
S062 2016-11-22 30-day Notice
S061 2016-11-01 30-day Notice
S060 2016-09-30 30-day Notice
S059 2016-09-28 30-day Notice
S058 2016-09-22 30-day Notice
S057 2016-09-13 30-day Notice
S056 2016-04-11 30-day Notice
S055 2016-02-08 30-day Notice
S054 2015-12-18 30-day Notice
S053 2015-11-25 30-day Notice
S052 2015-11-02 30-day Notice
S051 2015-04-09 30-day Notice
S050 2015-04-03 30-day Notice
S049 2014-12-23 30-day Notice
S048 2014-12-17 30-day Notice
S047 2014-08-12 30-day Notice
S046 2014-07-15 30-day Notice
S045 2014-06-26 30-day Notice
S044 2014-04-02 30-day Notice
S043 2014-03-14 30-day Notice
S042 2014-02-26 30-day Notice
S041 2013-11-18 Normal 180 Day Track
S040 2013-07-26 30-day Notice
S039 2013-04-02 30-day Notice
S038
S037 2013-02-05 30-day Notice
S036 2013-01-28 30-day Notice
S035 2012-12-21 30-day Notice
S034 2012-11-19 30-day Notice
S033 2012-07-06 30-day Notice
S032 2012-02-21 30-day Notice
S031 2012-01-11 30-day Notice
S030 2011-11-23 30-day Notice
S029
S028 2011-11-07 30-day Notice
S027 2011-09-30 30-day Notice
S026 2011-09-19 135 Review Track For 30-day Notice
S025 2011-09-12 30-day Notice
S024 2011-06-06 30-day Notice
S023 2011-05-23 30-day Notice
S022 2011-05-20 30-day Notice
S021 2011-05-17 30-day Notice
S020 2011-05-16 30-day Notice
S019 2011-05-12 30-day Notice
S018 2011-04-22 30-day Notice
S017 2010-10-08 30-day Notice
S016
S015 2010-08-23 30-day Notice
S014 2010-06-28 135 Review Track For 30-day Notice
S013 2010-04-02 30-day Notice
S012 2010-03-10 135 Review Track For 30-day Notice
S011 2010-02-12 30-day Notice
S010 2010-01-25 30-day Notice
S009 2009-10-13 30-day Notice
S008 2009-07-09 30-day Notice
S007 2009-06-22 Real-time Process
S006 2009-06-04 30-day Notice
S005 2009-05-20 30-day Notice
S004 2009-04-17 30-day Notice
S003 2007-11-20 Real-time Process
S002 2007-10-23 Normal 180 Day Track No User Fee
S001 2007-04-23 Normal 180 Day Track

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