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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode MOZ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Durolane, Hyaluronic Acid, Stabilized Single Injec... Bioventus LLC P170007 S005 12/18/2019
Gel-One SEIKAGAKU CORP. P080020 S035 10/30/2019
Durolane Bioventus LLC P170007 S004 09/19/2019
Durolane, Hyaluronic Acid, Stabilized Single Injec... Bioventus LLC P170007 S003 06/08/2019
EUFLEXXA (1% Sodium Hyaluronate) FERRING PHARMACEUTICALS, INC. P010029 S028 05/08/2019
TRILURON Fidia Farmaceutici S.p.A. P180040 03/26/2019
Gel-One SEIKAGAKU CORP. P080020 S032 03/13/2019
Gel-One SEIKAGAKU CORP. P080020 S033 03/13/2019
DUROLANE Bioventus LLC P170007 S002 03/13/2019
SUPARTZ FX; VISCO-3 SEIKAGAKU CORP. P980044 S051 01/18/2019
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