VISCOAT™ Ophthalmic Viscosurgical , DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),

FDA Premarket Approval P840064 S078

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

DeviceVISCOAT™ Ophthalmic Viscosurgical , DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),
Generic NameAid, Surgical, Viscoelastic
ApplicantALCON LABORATORIES6201 S Freewayft Worth, TX 76134 PMA NumberP840064 Supplement NumberS078 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-23
Decision Date2022-09-15
PMAP840064
SupplementS078
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressALCON LABORATORIES
6201 S Freeway
ft Worth, TX 76134 PMA NumberP840064 Supplement NumberS078 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Change To The Blister Seal Integrity Test Method For The Testing Of The OVD Blister

Supplemental Filings

Supplement NumberDateSupplement Type
P840064Original Filing
S078 2022-08-23 30-day Notice
S077 2022-08-17 30-day Notice
S076 2021-04-12 Normal 180 Day Track No User Fee
S075 2021-04-12 Normal 180 Day Track No User Fee
S074 2021-02-02 30-day Notice
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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