HYALGAN®

FDA Premarket Approval P950027 S017

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®
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFIDIA FARMACEUTICI SPAvia Ponte Della Fabbrica 3/aabano Terme, Padua (pd) 35031 PMA NumberP950027 Supplement NumberS017 Date Received09/08/2022 Decision Date10/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-09-08
Decision Date2022-10-04
PMAP950027
SupplementS017
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 NumberS017 Date Received09/08/2022 Decision Date10/04/2022 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  
a Change To The Storage Condition 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
M713891220724120 P950027 006
M713891220724200 P950027 006
05060459970052 P950027 014

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