HYALGAN

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P950027 S011

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

Approval for updating the section of adverse events with a qualitative description of the types and is indicated for the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e. G. , acetaminophen.

DeviceHYALGAN
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFIDIA FARMACEUTICI SPA
Date Received2008-02-20
Decision Date2008-05-23
PMAP950027
SupplementS011
Product CodeMOZ
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address FIDIA FARMACEUTICI SPA via Ponte Della Fabbrica 3/a abano Terme, Padua (pd) 35031

Supplemental Filings

Supplement NumberDateSupplement Type
P950027Original 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 IDPMASupp
M71389122072420A1 P950027 006
M71389122072412A1 P950027 006
M713891220724120 P950027 006
M713891220724200 P950027 006
05060459970052 P950027 014

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