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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 22 Results
productcode MOZ PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
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Gel-One SEIKAGAKU CORP. P080020 S038 07/17/2020
Synvisc, Synvisc-One Sanofi GENZYME CORP. P940015 S046 07/17/2020
SUPARTZ FX and VISCO-3 SEIKAGAKU CORP. P980044 S053 07/17/2020
GELSYN-3 IBSA INSTITUT BIOCHIMIQUE SA P110005 S004 07/10/2020
GenVisc 850 ORTHOGENRX,INC P140005 S004 06/07/2020
TriVisc ORTHOGENRX,INC P160057 S001 06/07/2020
EUFLEXXA (1% Sodium Hyaluronate) FERRING PHARMACEUTICALS, INC. P010029 S030 04/16/2020
Gel-One SEIKAGAKU CORP. P080020 S037 03/31/2020
Gel-One SEIKAGAKU CORP. P080020 S036 03/16/2020
Synvisc/Synvisc-One Sanofi GENZYME CORP. P940015 S045 01/16/2020
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