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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 23 Results
productcode MCX PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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Rotablator® Rotational Atherectomy System Boston Scientific Corp. P900056 S162 07/24/2017
Rotational Atherectomy System Boston Scientific Corp. P900056 S157 07/05/2017
AngioJet Rheolytic Thrombectomy System Boston Scientific Corp. P980037 S065 06/02/2017
Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corp. P900056 S161 05/26/2017
Rotablator® Rotational Atherectomy System Boston Scientific Corp. P900056 S160 05/12/2017
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S159 05/04/2017
Diamondback 360 Coronary Orbital Atherectomy Devic... CARDIOVASCULAR SYSTEMS, INC. P130005 S016 05/03/2017
AngioJet Ultra Thrombecomy System Conosle Boston Scientific Corp. P980037 S064 04/27/2017
Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corp. P900056 S158 03/24/2017
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVIC... CARDIOVASCULAR SYSTEMS, INC. P130005 S014 03/19/2017
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