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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 25 Results
productcode MCX PMA Number p Decision Date From 1/1/2015 Decision Date To 1/1/2016
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ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE Boston Scientific Corp. P980037 S047 09/17/2015
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM Boston Scientific Corp. P900056 S150 08/20/2015
ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER Boston Scientific Corp. P900056 S149 07/09/2015
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S005 07/07/2015
DIAMONDBACK 360 CORONARY ORIBITAL ATHERECTOMY SYST... CARDIOVASCULAR SYSTEMS, INC. P130005 S008 06/25/2015
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S009 06/25/2015
ROTAWIRE ELITE GUIDEWIRE Boston Scientific Corp. P900056 S145 06/19/2015
ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM Boston Scientific Corp. P900056 S147 06/12/2015
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE Boston Scientific Corp. P900056 S146 05/28/2015
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S004 05/14/2015
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