HYALGAN® (sodium hyaluronate)

FDA Premarket Approval P950027 S018

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

DeviceHYALGAN® (sodium hyaluronate)
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-23
Decision Date2023-01-19
PMAP950027
SupplementS018
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressFIDIA FARMACEUTICI SPA
via Ponte Della Fabbrica 3/a
abano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS018 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Change To The Manufacturing Procedure, Including Methods For Filtration And Washes For The Sodium Hyaluronate Bulk Powder.

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
05060459970052 P950027 014

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