TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Lens, Multifocal Intraocular

FDA Premarket Approval P080010

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the tecnis multifocal foldable posterior chamber intraocular lenses (iols), models zm900 and zma00. The devices are indicated for primary implantation for the visual correction of aphakia adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence.

DeviceTECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification NameLens, Multifocal Intraocular
Generic NameLens, Multifocal Intraocular
ApplicantJohnson & Johnson Surgical Vision, Inc.
Date Received2008-04-02
Decision Date2009-01-16
Notice Date2009-01-27
PMAP080010
SupplementS
Product CodeMFK
Docket Number09M-0034
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080010Original Filing
S021 2022-11-09 30-day Notice
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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