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.
Modification to the statistical method and procedures for product sampling of finished product release.
| Device | VISTAKON (SENOFILCON A) CONTACT LENS |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR |
| Date Received | 2016-04-11 |
| Decision Date | 2016-05-06 |
| PMA | P040045 |
| Supplement | S056 |
| 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 |