PROVISC™ Ophthalmic Viscosurgical

FDA Premarket Approval P890047 S059

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

DevicePROVISC™ Ophthalmic Viscosurgical
Generic NameAid, Surgical, Viscoelastic
ApplicantAlcon Research, Ltd.6201 South Freeway, R3-48fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS059 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
PMAP890047
SupplementS059
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAlcon Research, Ltd.
6201 South Freeway, R3-48
fort Worth, TX 76134-2099 PMA NumberP890047 Supplement NumberS059 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 ProductNo Approval Order Statement  
a Change To The Blister Seal Integrity Test Method For The Testing Of The OVD Blister

Supplemental Filings

Supplement NumberDateSupplement Type
P890047Original Filing
S059 2022-08-23 30-day Notice
S058 2022-08-17 30-day Notice
S057 2021-02-02 30-day Notice
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

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