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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 20 Results
productcode MCX PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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AngioJet Thrombectomy Catheter Boston Scientific Corp. P980037 S084 12/17/2020
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S031 12/10/2020
Rotablator Rotational Atherectomy System and ROTAP... Boston Scientific Corp. P900056 S191 11/23/2020
AngioJet Rheolytic Thrombectomy System Boston Scientific Corp. P980037 S083 11/12/2020
AngioJet Rheolytic Thrombectomy Catheter Boston Scientific Corp. P980037 S082 10/29/2020
Rotablator Rotational Atherectomy System and ROTAP... Boston Scientific Corp. P900056 S188 09/29/2020
Rotablator Rotational Atherectomy System and ROTAP... Boston Scientific Corp. P900056 S189 09/29/2020
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S190 09/25/2020
Rotablator Rotational Atherectomy System (Rotablat... Boston Scientific Corp. P900056 S187 09/10/2020
AngioJet Rheolytic Thrombectomy Catheter Boston Scientific Corp. P980037 S081 08/10/2020
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