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.
Implement a change in the finished product parameter measurement system for the vistakon® (etafilcon a) and (senofilcon a) brand contact lenses.
| Device | VISTAKON (SENOFILCON A) BRAND CONTACT LENSES |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
| Date Received | 2016-11-01 |
| Decision Date | 2016-11-22 |
| PMA | P040045 |
| Supplement | S061 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR 7500 Centurion Parkway suite 100 - Erca jacksonville, FL 32256 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040045 | Original Filing | |
| S129 | 2022-11-21 | 30-day Notice |
| S128 | 2022-08-04 | 30-day Notice |
| S127 | ||
| S126 | 2022-05-24 | 30-day Notice |
| S125 | 2022-05-17 | 30-day Notice |
| S124 | 2022-03-30 | 30-day Notice |
| S123 | 2021-11-12 | 30-day Notice |
| S122 | 2021-07-28 | 30-day Notice |
| S121 | 2021-05-10 | 30-day Notice |
| S120 | 2020-10-29 | 30-day Notice |
| S119 | 2020-10-26 | 30-day Notice |
| S118 | 2020-09-04 | Normal 180 Day Track |
| S117 | ||
| S116 | ||
| 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 |