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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode MCX PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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AngioJet Spiroflex Thrombectomy Set, AngioJet Spir... Boston Scientific Corp. P980037 S089 12/07/2022
Rotablator Rotational Atherectomy System Boston Scientific Corp. P900056 S203 11/15/2022
ROTAWIRE™ Guidewire Boston Scientific Corp. P900056 S202 10/17/2022
Rotablator™and ROTAPRO™ Rotational Atherectomy Sys... Boston Scientific Corp. P900056 S200 09/02/2022
AngioJet Rheolythic Thrombectomy Catheter System Boston Scientific Corp. P980037 S088 05/06/2022
Rotablator Rotational Angioplasty System, ROTAPRO ... Boston Scientific Corp. P900056 S199 04/28/2022
DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTE... CARDIOVASCULAR SYSTEMS, INC. P130005 S034 04/06/2022
ROTAPRO Rotational Atherectomy System Boston Scientific Corp. P900056 S198 03/30/2022
Diamondback 360 Coronary Orbital Atherectomy Syste... CARDIOVASCULAR SYSTEMS, INC. P130005 S035 03/11/2022
Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corp. P900056 S197 02/25/2022
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