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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode MCX PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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Rotablator Rotational Angioplasty System, ROTAPRO ... Boston Scientific Corp. P900056 S195 11/26/2021
Rotablator™and ROTAPRO™ Rotational Atherectomy Sys... Boston Scientific Corp. P900056 S194 10/05/2021
AngioJet Thrombectomy System Boston Scientific Corp. P980037 S086 08/12/2021
AngioJet Thrombectomy System Boston Scientific Corp. P980037 S085 08/11/2021
ROTAPRO Rotational Atherectomy System Boston Scientific Corp. P900056 S193 07/06/2021
Rotablator Rotational Atherectomy System (Rotablat... Boston Scientific Corp. P900056 S192 06/24/2021
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S033 04/23/2021
Rotablator or ROTAPRO Rotational Atherectomy Syste... Boston Scientific Corp. P900056 S183 02/05/2021
DIAMONDBACK 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S032 01/14/2021
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