BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID

Aid, Surgical, Viscoelastic

FDA Premarket Approval P960011

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

The device is indicated for use as a surgical aid to protect corneal endothelium during cataract extraction (extra-capsular), intraocular lens implantation and anterior segment surgery.

• Device: BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
• Classification Name: Aid, Surgical, Viscoelastic
• Generic Name: Aid, Surgical, Viscoelastic
• Applicant: Amring Pharmaceuticals
• Date Received: 1996-05-01
• Decision Date: 1998-07-16
• Notice Date: 1998-08-17
• PMA: P960011
• Supplement: S
• Product Code: LZP
• Docket Number: 98M-0604
• Advisory Committee: Ophthalmic
• Expedited Review: No
• Combination Product: No
• Applicant Address: Amring Pharmaceuticals 1235 Westlakes Drive suite 205 berwyn, PA 19312

Supplemental Filings

Supplement Number	Date	Supplement Type
P960011		Original Filing
S034	2022-09-08	30-day Notice
S033
S032	2019-05-07	Real-time Process
S031	2019-04-04	30-day Notice
S030	2018-03-30	30-day Notice
S029	2018-02-12	Special (immediate Track)
S028	2017-12-07	30-day Notice
S027	2017-12-06	30-day Notice
S026	2014-07-15	30-day Notice
S025	2014-04-28	30-day Notice
S024	2013-11-13	30-day Notice
S023	2013-05-08	30-day Notice
S022	2013-01-15	30-day Notice
S021	2012-03-05	30-day Notice
S020	2011-12-29	30-day Notice
S019	2011-03-02	30-day Notice
S018	2011-02-10	Special (immediate Track)
S017	2009-12-18	135 Review Track For 30-day Notice
S016	2009-12-07	30-day Notice
S015	2009-12-07	30-day Notice
S014	2009-11-09	30-day Notice
S013	2008-01-15	30-day Notice
S012	2006-11-01	Normal 180 Day Track No User Fee
S011	2006-09-18	Real-time Process
S010	2005-05-11	Normal 180 Day Track No User Fee
S009	2004-07-09	Normal 180 Day Track
S008	2002-03-18	Normal 180 Day Track
S007	2001-08-08	Normal 180 Day Track
S006	2000-09-27	135 Review Track For 30-day Notice
S005	2000-04-25	30-day Notice
S004	2000-04-11	Normal 180 Day Track
S003	1999-08-03	30-day Notice
S002	1999-03-29	Normal 180 Day Track
S001	1998-08-31	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
15060156070380	P960011	001
01369918000007	P960011	027