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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 20 Results
productcode MOZ PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Gel-One SEIKAGAKU CORP. P080020 S044 08/06/2021
SUPARTZ FX and VISCO-3 SEIKAGAKU CORP. P980044 S057 08/06/2021
Orthovisc Anika Therapeutics, Inc. P030019 S026 07/02/2021
Synvisc and Synvisc-One Sanofi GENZYME CORP. P940015 S048 06/29/2021
Gel-One SEIKAGAKU CORP. P080020 S043 05/26/2021
DUROLANE Bioventus LLC P170007 S009 05/25/2021
SUPARTZ device family, SUPARTZ FX and VISCO-3 SEIKAGAKU CORP. P980044 S056 05/24/2021
Gel-One SEIKAGAKU CORP. P080020 S042 04/15/2021
SUPARTZ device family, SUPARTZ FX and VISCO-3 SEIKAGAKU CORP. P980044 S055 04/15/2021
GELSYN-3 IBSA INSTITUT BIOCHIMIQUE SA P110005 S008 03/15/2021
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