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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 16 Results
productcode MOZ PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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EUFLEXXA (1% Sodium Hyaluronate) FERRING PHARMACEUTICALS, INC. P010029 S025 12/28/2017
Gel-One SEIKAGAKU CORP. P080020 S027 12/14/2017
SUPARTZ FX / VISCO-3 SEIKAGAKU CORP. P980044 S041 12/14/2017
TRIVISC ORTHOGENRX,INC P160057 11/13/2017
DUROLANE Bioventus LLC P170007 08/29/2017
MONOVISC High Molecular Weight Hyaluronan Anika Therapeutics, Inc. P090031 S008 08/21/2017
SUPARTZ FX and VISCO-3 SEIKAGAKU CORP. P980044 S040 07/28/2017
SYNVISC ONE Sanofi GENZYME CORP. P940015 S040 05/11/2017
Synvisc Sanofi GENZYME CORP. P940015 S039 03/29/2017
Supartz FX and Visco-3 SEIKAGAKU CORP. P980044 S038 03/29/2017
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