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.
Device | JJSV’s intraocular lenses (IOLs) |
Generic Name | Intraocular Lens |
Applicant | Johnson & Johnson Surgical Vision, Inc.1700 E. St. Andrew Placesanta Ana, CA 92705 PMA NumberP980040 Supplement NumberS147 Date Received04/28/2022 Decision Date05/18/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-04-28 |
Decision Date | 2022-05-18 |
PMA | P980040 |
Supplement | S147 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 PMA NumberP980040 Supplement NumberS147 Date Received04/28/2022 Decision Date05/18/2022 Product Code HQL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Perform The Flat Time Test Prior To Sterilization As Opposed To Post Sterilization |
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 |