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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 18 Results
productcode MCX PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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DIAMONDBACK 360 Precision Coronary Orbital Atherec... CARDIOVASCULAR SYSTEMS, INC. P130005 S040 12/14/2023
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S212 12/12/2023
ROTAPRO™ Rotational Atherectomy System Boston Scientific Corp. P900056 S213 12/12/2023
Rotablator™and ROTAPRO™ Rotational Atherectomy Sys... Boston Scientific Corp. P900056 S214 12/06/2023
DIAMONDBACK 360® Coronary Orbital Atherectomy Syst... CARDIOVASCULAR SYSTEMS, INC. P130005 S041 11/27/2023
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S039 10/24/2023
ROTAPRO™ and Rotalink Rotational Atherectomy Syste... Boston Scientific Corp. P900056 S211 09/28/2023
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S038 09/07/2023
Rotablator™, ROTAPRO™ Rotational Atherectomy Syste... Boston Scientific Corp. P900056 S210 08/29/2023
Rotaglide Lubricant Boston Scientific Corp. P900056 S201 08/17/2023
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