HYALGAN

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P950027 S012

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

Addition of a new, fully automated filling and closing machine.

• Device: HYALGAN
• Classification Name: Acid, Hyaluronic, Intraarticular
• Generic Name: Acid, Hyaluronic, Intraarticular
• Applicant: FIDIA FARMACEUTICI SPA
• Date Received: 2010-02-26
• Decision Date: 2010-03-28
• PMA: P950027
• Supplement: S012
• Product Code: MOZ
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: FIDIA FARMACEUTICI SPA via Ponte Della Fabbrica 3/a abano Terme, Padua (pd) 35031

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