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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 23 Results
productcode MCX PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S168 12/01/2017
Diamondback 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S020 11/17/2017
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S165 11/02/2017
Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corp. P900056 S167 11/01/2017
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S018 10/20/2017
AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Di... Boston Scientific Corp. P980037 S066 10/16/2017
AngioJet Ultra Thrombectomy System Boston Scientific Corp. P980037 S067 09/28/2017
Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corp. P900056 S164 08/31/2017
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S163 08/17/2017
DIAMONDBACK 360 Orbital Atherectomy System CARDIOVASCULAR SYSTEMS, INC. P130005 S017 08/02/2017
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