HYALGAN(R)

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P950027 S003

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 modification of labeling and additional information about the current clinical experience of the device as detailed in amendment received 12/10/99.

DeviceHYALGAN(R)
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFIDIA FARMACEUTICI SPA
Date Received1998-08-24
Decision Date1999-12-18
PMAP950027
SupplementS003
Product CodeMOZ
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
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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