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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 4 of 4 Results
productcode MCX PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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Device
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PMA
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Decision
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DIAMONDBACK 360 Precision Coronary Orbital Atherec... CARDIOVASCULAR SYSTEMS, INC. P130005 S042 05/02/2024
Rotablator and ROTAPRO Rotational Atherectomy Syst... Boston Scientific Corp. P900056 S216 03/15/2024
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S215 03/13/2024
AngioJet Rheolythic Thrombectomy Catheter Boston Scientific Corp. P980037 S091 03/13/2024
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