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.
Approval for changes to the protocol for the post-approval study (pas) protocol.
| Device | TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600 |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2017-01-05 |
| Decision Date | 2017-03-03 |
| PMA | P980040 |
| Supplement | S077 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980040 | Original Filing | |
| S155 | 2022-11-18 | 30-day Notice |
| S154 | 2022-11-17 | 30-day Notice |
| S153 | ||
| S152 | 2022-10-25 | 30-day Notice |
| S151 | 2022-09-28 | 30-day Notice |
| S150 | 2022-09-12 | 30-day Notice |
| S149 | 2022-07-01 | 30-day Notice |
| S148 | 2022-06-24 | 30-day Notice |
| S147 | 2022-04-28 | 30-day Notice |
| S146 | 2022-03-02 | 30-day Notice |
| S145 | 2022-01-24 | 30-day Notice |
| S144 | 2021-12-20 | Normal 180 Day Track |
| S143 | ||
| S142 | 2021-10-01 | Real-time Process |
| S141 | 2021-07-06 | 30-day Notice |
| S140 | ||
| S139 | ||
| S138 | 2021-06-04 | 30-day Notice |
| S137 | 2021-06-03 | 30-day Notice |
| S136 | 2021-05-21 | Normal 180 Day Track No User Fee |
| S135 | 2021-05-10 | 30-day Notice |
| S134 | 2021-04-06 | 30-day Notice |
| S133 | ||
| S132 | 2021-02-25 | 30-day Notice |
| S131 | 2021-02-09 | 30-day Notice |
| S130 | 2021-01-27 | 30-day Notice |
| S129 | 2021-01-05 | 30-day Notice |
| S128 | 2020-12-16 | 30-day Notice |
| S127 | 2020-12-10 | 30-day Notice |
| S126 | 2020-10-16 | 30-day Notice |
| S125 | ||
| S124 | ||
| S123 | 2020-10-01 | 30-day Notice |
| S122 | 2020-09-03 | 30-day Notice |
| S121 | 2020-08-25 | 30-day Notice |
| S120 | ||
| S119 | 2020-07-06 | 30-day Notice |
| S118 | ||
| S117 | ||
| S116 | ||
| S115 | ||
| S114 | ||
| S113 | ||
| S112 | 2020-02-28 | Real-time Process |
| S111 | ||
| S110 | 2019-11-08 | 30-day Notice |
| S109 | ||
| S108 | 2019-09-16 | 30-day Notice |
| S107 | ||
| S106 | 2019-08-19 | 30-day Notice |
| S105 | 2019-07-16 | 30-day Notice |
| S104 | 2019-06-19 | 30-day Notice |
| S103 | ||
| S102 | 2019-03-04 | 30-day Notice |
| S101 | 2019-02-26 | 30-day Notice |
| S100 | ||
| S099 | ||
| S098 | ||
| S097 | 2018-12-21 | 30-day Notice |
| S096 | 2018-12-21 | 30-day Notice |
| S095 | ||
| S094 | 2018-11-20 | 30-day Notice |
| S093 | 2018-09-19 | Normal 180 Day Track No User Fee |
| S092 | 2018-06-27 | 30-day Notice |
| S091 | 2018-05-15 | 30-day Notice |
| S090 | 2018-05-15 | 30-day Notice |
| S089 | 2018-05-04 | 135 Review Track For 30-day Notice |
| S088 | 2018-04-11 | 30-day Notice |
| S087 | 2018-03-19 | 30-day Notice |
| S086 | 2018-02-16 | Normal 180 Day Track No User Fee |
| S085 | 2017-11-20 | 30-day Notice |
| S084 | 2017-09-28 | 30-day Notice |
| S083 | 2017-08-28 | 30-day Notice |
| S082 | 2017-05-12 | 30-day Notice |
| S081 | 2017-04-25 | 30-day Notice |
| S080 | 2017-04-10 | Normal 180 Day Track No User Fee |
| S079 | 2017-02-23 | 30-day Notice |
| S078 | 2017-02-22 | 30-day Notice |
| S077 | 2017-01-05 | Normal 180 Day Track No User Fee |
| S076 | 2016-11-14 | 30-day Notice |
| S075 | 2016-11-02 | 30-day Notice |
| S074 | 2016-09-09 | 30-day Notice |
| S073 | 2016-08-22 | 30-day Notice |
| S072 | 2016-08-15 | Normal 180 Day Track No User Fee |
| S071 | 2016-06-02 | 30-day Notice |
| S070 | 2016-06-01 | 30-day Notice |
| S069 | 2016-05-18 | 30-day Notice |
| S068 | 2016-04-18 | 30-day Notice |
| S067 | 2016-03-21 | Normal 180 Day Track No User Fee |
| S066 | 2016-01-28 | Normal 180 Day Track |
| S065 | 2016-01-19 | Panel Track |
| S064 | 2015-12-18 | 30-day Notice |
| S063 | 2015-11-17 | 30-day Notice |
| S062 | 2015-04-02 | Normal 180 Day Track No User Fee |
| S061 | 2015-04-01 | 30-day Notice |
| S060 | 2015-03-23 | 30-day Notice |
| S059 | 2015-02-20 | Normal 180 Day Track |
| S058 | 2015-02-02 | Normal 180 Day Track |
| S057 | 2015-01-29 | Real-time Process |
| S056 | 2014-12-24 | Normal 180 Day Track |
| S055 | 2014-12-03 | 30-day Notice |
| S054 | 2014-11-18 | 30-day Notice |
| S053 | 2014-10-20 | 30-day Notice |
| S052 | 2014-10-20 | 30-day Notice |
| S051 | 2014-10-16 | 30-day Notice |
| S050 | 2014-09-24 | 30-day Notice |
| S049 | 2014-06-30 | Panel Track |
| S048 | 2014-06-13 | Normal 180 Day Track No User Fee |
| S047 | 2013-11-26 | 30-day Notice |
| S046 | 2013-10-17 | Normal 180 Day Track |
| S045 | 2013-05-24 | 30-day Notice |
| S044 | 2013-05-15 | Normal 180 Day Track No User Fee |
| S043 | 2013-05-15 | Normal 180 Day Track No User Fee |
| S042 | 2013-02-12 | 30-day Notice |
| S041 | 2012-09-04 | Normal 180 Day Track |
| S040 | 2012-04-23 | 30-day Notice |
| S039 | 2012-04-09 | Panel Track |
| S038 | 2012-01-30 | 30-day Notice |
| S037 | 2011-11-14 | 135 Review Track For 30-day Notice |
| S036 | ||
| S035 | 2010-10-18 | Normal 180 Day Track |
| S034 | 2010-06-10 | 30-day Notice |
| S033 | 2010-04-22 | 30-day Notice |
| S032 | 2010-02-18 | 30-day Notice |
| S031 | ||
| S030 | 2009-07-30 | 135 Review Track For 30-day Notice |
| S029 | 2009-07-09 | Normal 180 Day Track |
| S028 | 2009-06-30 | 30-day Notice |
| S027 | 2009-06-09 | 30-day Notice |
| S026 | 2008-11-24 | 30-day Notice |
| S025 | 2008-08-29 | 30-day Notice |
| S024 | 2008-06-02 | 30-day Notice |
| S023 | 2008-03-21 | Normal 180 Day Track |
| S022 | 2007-12-21 | Normal 180 Day Track No User Fee |
| S021 | 2007-12-17 | 135 Review Track For 30-day Notice |
| S020 | 2007-12-14 | 30-day Notice |
| S019 | 2007-10-02 | 30-day Notice |
| S018 | 2007-09-24 | 30-day Notice |
| S017 | 2007-08-09 | 30-day Notice |
| S016 | 2007-06-13 | 30-day Notice |
| S015 | 2007-05-18 | Normal 180 Day Track |
| S014 | 2007-03-28 | 30-day Notice |
| S013 | 2007-03-27 | 30-day Notice |
| S012 | 2007-02-20 | 30-day Notice |
| S011 | 2007-02-20 | 30-day Notice |
| S010 | 2006-12-18 | 30-day Notice |
| S009 | 2006-12-18 | 30-day Notice |
| S008 | 2006-09-13 | 30-day Notice |
| S007 | 2005-09-30 | Normal 180 Day Track |
| S006 | 2005-01-03 | Real-time Process |
| S005 | 2003-10-31 | Real-time Process |
| S004 | ||
| S003 | 2001-11-19 | Normal 180 Day Track |
| S002 | 2001-04-30 | Normal 180 Day Track |
| S001 | 2001-03-08 | Normal 180 Day Track |