VISTAKON (Senofilcon A) Brand Contact Lenses

FDA Premarket Approval P040045 S115

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

Qualification of an external supplier used to repackage vistakon® (senofilcon a) brand contact lenses

DeviceVISTAKON (Senofilcon A) Brand Contact Lenses
Generic NameLenses, Soft Contact, Extended Wear
ApplicantVISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR
Date Received2020-05-19
Decision Date2020-06-16
PMAP040045
SupplementS115
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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