TECNIS Foldable Acrylic IOL

FDA Premarket Approval P990080 S054

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

Adding an alternative supplier for the thermal initiator used at the johnson and johnson surgical vision, inc. (jjsv) añasco facility in puerto rico for iol production

DeviceTECNIS Foldable Acrylic IOL
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-10-16
Decision Date2020-11-12
PMAP990080
SupplementS054
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
P990080Original Filing
S054 2020-10-16 30-day Notice
S053
S052
S051 2019-09-16 30-day Notice
S050 2019-03-04 30-day Notice
S049 2019-02-26 30-day Notice
S048 2018-12-21 30-day Notice
S047 2018-12-21 30-day Notice
S046 2018-04-11 30-day Notice
S045 2017-09-28 30-day Notice
S044 2016-11-02 30-day Notice
S043 2016-06-02 30-day Notice
S042 2016-06-01 30-day Notice
S041 2016-05-18 30-day Notice
S040 2015-12-18 30-day Notice
S039 2015-04-01 30-day Notice
S038 2013-05-24 30-day Notice
S037 2012-04-23 30-day Notice
S036 2011-11-14 135 Review Track For 30-day Notice
S035
S034
S033 2009-07-30 135 Review Track For 30-day Notice
S032 2008-11-24 30-day Notice
S031 2008-08-29 30-day Notice
S030 2007-12-17 135 Review Track For 30-day Notice
S029 2007-12-14 30-day Notice
S028 2007-10-02 30-day Notice
S027 2007-09-24 30-day Notice
S026 2007-08-09 30-day Notice
S025 2007-06-13 30-day Notice
S024 2007-05-09 Normal 180 Day Track No User Fee
S023 2007-04-12 30-day Notice
S022 2007-03-28 30-day Notice
S021 2007-03-27 30-day Notice
S020 2007-02-20 30-day Notice
S019 2007-02-20 30-day Notice
S018 2006-12-19 30-day Notice
S017 2006-12-19 30-day Notice
S016 2006-12-18 30-day Notice
S015 2006-12-18 30-day Notice
S014 2006-12-18 30-day Notice
S013 2006-12-18 30-day Notice
S012 2006-10-12 30-day Notice
S011 2006-10-12 30-day Notice
S010 2006-10-12 30-day Notice
S009 2006-10-10 30-day Notice
S008 2006-05-23 135 Review Track For 30-day Notice
S007
S006 2005-03-14 Real-time Process
S005 2005-01-03 Real-time Process
S004 2003-04-15 Normal 180 Day Track
S003 2002-12-23 Real-time Process
S002 2002-09-13 Real-time Process
S001 2001-09-05 Real-time Process

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