PROVISC Ophthalmic Viscosurgical

FDA Premarket Approval P890047 S056

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

DevicePROVISC Ophthalmic Viscosurgical
Generic NameAid, Surgical, Viscoelastic
ApplicantAlcon Research, Ltd.
Date Received2020-10-05
Decision Date2020-10-23
PMAP890047
SupplementS056
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Research, Ltd. 6201 South Freeway, R3-48 fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P890047Original Filing
S056 2020-10-05 30-day Notice
S055 2020-08-20 30-day Notice
S054 2020-03-09 30-day Notice
S053 2018-03-27 30-day Notice
S052 2017-10-18 30-day Notice
S051 2017-03-07 Real-time Process
S050 2017-02-15 30-day Notice
S049 2017-02-01 135 Review Track For 30-day Notice
S048 2016-07-21 Normal 180 Day Track No User Fee
S047 2016-04-25 30-day Notice
S046 2015-05-13 30-day Notice
S045 2014-11-12 30-day Notice
S044 2014-09-29 30-day Notice
S043 2014-04-02 30-day Notice
S042 2013-08-16 Normal 180 Day Track
S041 2013-07-12 30-day Notice
S040 2013-03-08 30-day Notice
S039 2012-07-03 30-day Notice
S038 2012-02-14 30-day Notice
S037 2012-01-05 30-day Notice
S036 2012-01-05 30-day Notice
S035 2011-12-22 30-day Notice
S034 2011-04-19 30-day Notice
S033 2010-10-15 30-day Notice
S032 2010-09-20 135 Review Track For 30-day Notice
S031 2010-05-24 30-day Notice
S030 2010-05-24 30-day Notice
S029 2009-09-15 30-day Notice
S028 2009-02-20 135 Review Track For 30-day Notice
S027 2008-11-24 30-day Notice
S026 2008-10-31 135 Review Track For 30-day Notice
S025 2008-10-31 30-day Notice
S024 2008-10-09 Normal 180 Day Track No User Fee
S023 2008-04-08 30-day Notice
S022 2007-12-26 Normal 180 Day Track
S021 2007-12-11 30-day Notice
S020 2007-11-14 30-day Notice
S019 2007-06-12 Normal 180 Day Track No User Fee
S018 2006-05-18 30-day Notice
S017 2005-07-06 30-day Notice
S016 2004-02-17 Real-time Process
S015 2003-04-24 Special (immediate Track)
S014 2002-02-20 Special (immediate Track)
S013 2000-12-15 Special (immediate Track)
S012
S011 1996-12-04 Normal 180 Day Track
S010 1995-12-27 Normal 180 Day Track
S009 1995-09-22 Normal 180 Day Track
S008 1995-08-14 Normal 180 Day Track
S007 1995-05-30 Normal 180 Day Track
S006
S005 1995-01-10 Normal 180 Day Track
S004 1994-06-02 Normal 180 Day Track
S003 1994-05-12 Normal 180 Day Track
S002 1993-12-28 Normal 180 Day Track
S001 1992-11-17 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380651830851 P890047 000
00380651830554 P890047 000
00380651830042 P890047 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.