TECNIS Multifocal Foldable Posterior Chamber IOL

FDA Premarket Approval P080010 S020

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 Multifocal Foldable Posterior Chamber IOL
Generic NameLens, Multifocal Intraocular
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2020-12-10
Decision Date2021-01-08
PMAP080010
SupplementS020
Product CodeMFK 
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
P080010Original Filing
S020 2020-12-10 30-day Notice
S019
S018 2019-02-26 30-day Notice
S017 2018-12-21 30-day Notice
S016 2018-12-21 30-day Notice
S015 2018-04-11 30-day Notice
S014 2017-09-28 30-day Notice
S013 2016-06-01 30-day Notice
S012 2015-12-18 30-day Notice
S011 2015-06-26 30-day Notice
S010 2013-11-26 30-day Notice
S009 2013-05-24 30-day Notice
S008 2012-04-23 30-day Notice
S007 2012-01-30 30-day Notice
S006
S005 2010-04-01 30-day Notice
S004 2009-06-30 30-day Notice
S003 2009-06-09 30-day Notice
S002 2009-04-28 Normal 180 Day Track No User Fee
S001 2009-01-27 Normal 180 Day Track

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