HYALGAN(R)

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P950027

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 the treatment of pain in osteoarthritis (oa) of theknee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen

• Device: HYALGAN(R)
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: FIDIA FARMACEUTICI SPA
• Date Received: 1995-07-28
• Decision Date: 1997-05-28
• Notice Date: 1998-12-07
• PMA: P950027
• Supplement: S
• Product Code: MOZ
• Docket Number: 98M-0980
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: FIDIA FARMACEUTICI SPA via Ponte Della Fabbrica 3/a abano Terme, Padua (pd) 35031
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P950027		Original Filing
S018	2022-12-23	30-day Notice
S017	2022-09-08	30-day Notice
S016	2022-07-11	30-day Notice
S015	2016-08-01	30-day Notice
S014	2013-08-29	Real-time Process
S013
S012	2010-02-26	30-day Notice
S011	2008-02-20	Real-time Process
S010	2007-12-07	Special (immediate Track)
S009	2007-06-20	Normal 180 Day Track
S008
S007
S006	2005-01-07	Real-time Process
S005
S004	1998-12-23	Normal 180 Day Track
S003	1998-08-24	Normal 180 Day Track
S002	1998-08-05	Normal 180 Day Track
S001	1997-06-24	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
M71389122072420A1	P950027	006
M71389122072412A1	P950027	006
M713891220724120	P950027	006
M713891220724200	P950027	006
05060459970052	P950027	014