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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 16 Results
productcode MCX PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM Boston Scientific Corp. P900056 S156 12/19/2016
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM Boston Scientific Corp. P980037 S062 12/14/2016
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM, ANGIOJET U... Boston Scientific Corp. P980037 S060 12/01/2016
AngioJet Ultra Thrombectomy System Console Boston Scientific Corp. P980037 S061 12/01/2016
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S012 10/26/2016
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S155 10/11/2016
ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTA... Boston Scientific Corp. P980037 S058 08/18/2016
ROTABLATOR Rotational Atherectomy System Boston Scientific Corp. P900056 S154 08/10/2016
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S013 06/07/2016
Rotablator Rotational Atherectomy System (ROTAWIRE... Boston Scientific Corp. P900056 S153 05/25/2016
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