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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 19 Results
productcode MRA PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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Trident Ceramic System HOWMEDICA OSTEONICS CORP. P000013 S021 12/20/2023
Trident(R), ABC(R) HOWMEDICA OSTEONICS CORP. P000013 S023 12/19/2023
Cermax® Ceramic Total Hip System DEPUY ORTHOPAEDICS, INC. P070026 S109 12/19/2023
R3 Delta Ceramic Hip System Smith & Nephew, Inc. P150030 S038 12/13/2023
CERAMAX Ceramic Total Hip System DEPUY ORTHOPAEDICS, INC. P070026 S110 10/05/2023
Trident®, ABC® HOWMEDICA OSTEONICS CORP. P000013 S022 09/27/2023
Ceramic TRANSCEND® Hip Articulation System CERAMTEC GMBH P010001 S026 09/06/2023
CERAMAX Ceramic Total Hip System DEPUY ORTHOPAEDICS, INC. P070026 S107 08/11/2023
R3 DELTA CERAMIC HIP SYSTEM Smith & Nephew, Inc. P150030 S035 08/11/2023
R3 Delta Ceramic Hip System Smith & Nephew, Inc. P150030 S031 07/28/2023
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