TRILURON® (sodium hyaluronate)

FDA Premarket Approval P180040 S004

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

DeviceTRILURON® (sodium hyaluronate)
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantFidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 Supplement NumberS004 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
PMAP180040
SupplementS004
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressFidia Farmaceutici S.p.A.
via Ponte Della Fabbrica 3/a
abano Terme 35031 PMA NumberP180040 Supplement NumberS004 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  
a Change To The Manufacturing Procedure, Including Methods For Filtration And Washes For The Sodium Hyaluronate Bulk Powder

Supplemental Filings

Supplement NumberDateSupplement Type
P180040Original Filing
S004 2022-12-23 30-day Notice
S003 2022-09-08 30-day Notice
S002 2022-07-11 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
M71389122087901SAM1 P180040 000
M71389122087901A1 P180040 000

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