VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI

FDA Premarket Approval P840064 S073

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

An alternate release testing site for raw materials and primary packaging components in the production of viscoat, provisc, duovisc, and discovisc

DeviceVISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI
Generic NameAid, Surgical, Viscoelastic
ApplicantALCON LABORATORIES
Date Received2020-10-05
Decision Date2020-10-23
PMAP840064
SupplementS073
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P840064Original Filing
S073 2020-10-05 30-day Notice
S072 2020-08-20 30-day Notice
S071 2020-03-09 30-day Notice
S070 2018-08-07 135 Review Track For 30-day Notice
S069 2018-06-01 30-day Notice
S068 2018-03-27 30-day Notice
S067 2017-10-18 30-day Notice
S066 2017-03-07 Real-time Process
S065 2017-02-15 30-day Notice
S064 2017-02-01 135 Review Track For 30-day Notice
S063 2016-10-24 30-day Notice
S062 2016-07-21 Normal 180 Day Track No User Fee
S061 2016-04-25 30-day Notice
S060 2015-05-13 30-day Notice
S059 2015-01-23 Normal 180 Day Track
S058 2014-11-12 30-day Notice
S057 2014-09-29 30-day Notice
S056 2014-04-02 30-day Notice
S055 2013-07-12 30-day Notice
S054 2013-06-28 30-day Notice
S053 2013-03-08 30-day Notice
S052 2012-11-13 30-day Notice
S051 2012-07-03 30-day Notice
S050 2012-02-14 30-day Notice
S049 2012-01-05 30-day Notice
S048 2012-01-05 30-day Notice
S047 2011-12-22 30-day Notice
S046 2011-04-19 30-day Notice
S045 2010-10-15 30-day Notice
S044 2010-09-20 135 Review Track For 30-day Notice
S043 2010-05-24 30-day Notice
S042 2010-05-24 30-day Notice
S041 2009-09-15 30-day Notice
S040 2009-02-20 135 Review Track For 30-day Notice
S039 2008-11-24 30-day Notice
S038 2008-10-31 135 Review Track For 30-day Notice
S037 2008-10-31 30-day Notice
S036 2008-10-09 Normal 180 Day Track No User Fee
S035 2008-04-08 30-day Notice
S034 2007-12-11 30-day Notice
S033 2007-11-14 30-day Notice
S032 2007-06-12 Normal 180 Day Track No User Fee
S031 2006-05-18 30-day Notice
S030 2005-12-05 30-day Notice
S029 2005-08-10 Real-time Process
S028 2005-07-06 30-day Notice
S027 2005-04-05 Real-time Process
S026 2004-06-21 Normal 180 Day Track
S025 2004-02-17 Real-time Process
S024 2003-04-24 Special (immediate Track)
S023 2002-02-20 Special (immediate Track)
S022 2000-12-15 Special (immediate Track)
S021 1998-03-23 Normal 180 Day Track
S020 1996-12-04 Normal 180 Day Track
S019 1996-12-04 Normal 180 Day Track
S018
S017 1995-12-26 Normal 180 Day Track
S016 1995-09-22 Normal 180 Day Track
S015 1995-08-14 Normal 180 Day Track
S014 1995-05-30 Normal 180 Day Track
S013
S012 1995-01-10 Normal 180 Day Track
S011 1993-12-28 Normal 180 Day Track
S010 1990-06-18 Normal 180 Day Track
S009 1990-03-16 Normal 180 Day Track
S008 1989-10-11 Normal 180 Day Track
S007 1989-08-23 Normal 180 Day Track
S006 1987-10-21 Normal 180 Day Track
S005 1987-08-21 Normal 180 Day Track
S004 1987-05-06 Normal 180 Day Track
S003 1987-03-05 Normal 180 Day Track
S002 1986-12-08 Normal 180 Day Track
S001 1986-12-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380651839755 P840064 001
00380651839052 P840064 001
00380651837102 P840064 026

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