PROVISC(TM)VISCOELASTIC PREPARATION

Aid, Surgical, Viscoelastic

FDA Premarket Approval P890047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

• Device: PROVISC(TM)VISCOELASTIC PREPARATION
• Classification Name: Aid, Surgical, Viscoelastic
• Generic Name: Aid, Surgical, Viscoelastic
• Applicant: Alcon Research, Ltd.
• Date Received: 1989-08-23
• Decision Date: 1991-09-26
• Notice Date: 1991-10-31
• PMA: P890047
• Supplement: S
• Product Code: LZP
• Docket Number: 91M-0394
• Advisory Committee: Ophthalmic
• Expedited Review: No
• Combination Product: No
• Applicant Address: Alcon Research, Ltd. 6201 South Freeway, R3-48 fort Worth, TX 76134-2099

Supplemental Filings

Supplement Number	Date	Supplement Type
P890047		Original 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 ID	PMA	Supp
00380651830851	P890047	000
00380651830554	P890047	000
00380651830042	P890047	000