TECNIS Foldable Acrylic IOL

FDA Premarket Approval P990080 S055

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

Alternate ethylene oxide sterilization cycle parameters

DeviceTECNIS Foldable Acrylic IOL
Generic NameIntraocular Lens
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-12-10
Decision Date2021-01-08
PMAP990080
SupplementS055
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
S055 2020-12-10 30-day Notice
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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