TECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System

FDA Premarket Approval P980040 S122

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

Addition of a raw material supplier for the polymer resin used to mold the pushrod component in the tecnis itec preloaded delivery system and in the tecnis simplicity delivery system

DeviceTECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-09-03
Decision Date2020-09-23
PMAP980040
SupplementS122
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P980040Original Filing
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

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