EUFLEXXA (1% SODIUM HYALURONATE)

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P010029

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

Approval for nuflexxa (1% sodium hyaluronate). The device is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e. G. , acetaminophen).

• Device: EUFLEXXA (1% SODIUM HYALURONATE)
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: FERRING PHARMACEUTICALS, INC.
• Date Received: 2001-05-01
• Decision Date: 2004-12-03
• Notice Date: 2006-08-24
• PMA: P010029
• Supplement: S
• Product Code: MOZ
• Docket Number: 06M-0338
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: FERRING PHARMACEUTICALS, INC. 100 Interpace Parkway parsippany, NJ 07054
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P010029		Original Filing
S030	2020-04-02	30-day Notice
S029	2019-12-09	30-day Notice
S028	2019-04-05	30-day Notice
S027	2018-08-22	Real-time Process
S026	2018-03-29	30-day Notice
S025	2017-06-20	Normal 180 Day Track No User Fee
S024	2015-04-23	30-day Notice
S023	2015-03-06	30-day Notice
S022	2015-02-09	30-day Notice
S021	2014-12-24	30-day Notice
S020	2014-04-28	30-day Notice
S019	2014-02-20	30-day Notice
S018	2013-11-13	30-day Notice
S017	2013-05-08	30-day Notice
S016	2013-01-15	30-day Notice
S015	2012-04-05	30-day Notice
S014	2012-03-05	30-day Notice
S013	2011-12-29	30-day Notice
S012	2011-03-02	30-day Notice
S011	2009-12-07	30-day Notice
S010	2009-11-17	135 Review Track For 30-day Notice
S009	2009-11-09	30-day Notice
S008	2009-03-30	Panel Track
S007	2008-05-02	135 Review Track For 30-day Notice
S006	2007-03-22	Real-time Process
S005
S004	2006-09-18	Real-time Process
S003
S002	2005-10-05	Normal 180 Day Track No User Fee
S001	2005-01-13	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
05060548950064	P010029	000
07640128544210	P010029	001
05060459970045	P010029	024