PMMA Single-Piece Anterior Chamber Intraocular Lens

FDA Premarket Approval P880087 S030

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

Approval of the introduction of the turbidimetric test method for the detection of endotoxin levels for pmma, acrysof and acrysof restor intraocular lenses (iols), acrysert and ultrasert lens delivery systems and purified water at alcon huntington west virginia

DevicePMMA Single-Piece Anterior Chamber Intraocular Lens
Generic NameIntraocular Lens
ApplicantALCON LABORATORIES
Date Received2020-11-25
Decision Date2020-12-17
PMAP880087
SupplementS030
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P880087Original Filing
S030 2020-11-25 30-day Notice
S029 2019-07-05 30-day Notice
S028 2019-03-25 30-day Notice
S027 2019-03-25 30-day Notice
S026 2016-11-30 30-day Notice
S025 2016-08-03 30-day Notice
S024
S023 2015-12-09 30-day Notice
S022 2013-04-22 30-day Notice
S021 2012-12-26 Normal 180 Day Track No User Fee
S020 2012-10-01 30-day Notice
S019 2011-06-24 30-day Notice
S018 2010-08-25 30-day Notice
S017 2010-08-10 30-day Notice
S016 2010-05-03 30-day Notice
S015 2010-05-03 30-day Notice
S014 2009-12-24 30-day Notice
S013 2009-06-30 30-day Notice
S012 2006-07-24 30-day Notice
S011 2004-10-18 135 Review Track For 30-day Notice
S010 2004-04-16 Real-time Process
S009 1996-10-24 Normal 180 Day Track
S008
S007 1996-08-08 Normal 180 Day Track
S006 1995-08-09 Normal 180 Day Track
S005 1995-01-31 Normal 180 Day Track
S004 1991-08-21 Normal 180 Day Track
S003
S002 1990-03-26 Normal 180 Day Track
S001

NIH GUDID Devices

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