SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0

FDA Premarket Approval P980040 S152

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

DeviceSENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP980040 Supplement NumberS152 Date Received10/25/2022 Decision Date11/17/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-25
Decision Date2022-11-17
PMAP980040
SupplementS152
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressJohnson & Johnson Surgical Vision, Inc.
31 Technology Drive
suite 200
irvine, CA 92618 PMA NumberP980040 Supplement NumberS152 Date Received10/25/2022 Decision Date11/17/2022 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  
expansion Of The Manufacturing Facility In Building 3 Of The Puerto Rico Facility

Supplemental Filings

Supplement NumberDateSupplement Type
P980040Original Filing
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

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.