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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 62 Results
productcode NIK PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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CRT-D Resynchronization Devices Boston Scientific Corp. P010012 S559 12/20/2022
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-... Boston Scientific Corp. P010012 S566 12/20/2022
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S565 12/14/2022
Cardiac Resynchronization Therapy Defibrillator (C... Boston Scientific Corp. P010012 S560 12/12/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S808 11/22/2022
Bi-Directional Torque Wrench Model 6628 Boston Scientific Corp. P010012 S558 11/15/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S805 11/03/2022
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S564 11/02/2022
ICD ORIGEN CRT-D, MOMENTUM CRT-D, ICD INOGEN CRT-D... Boston Scientific Corp. P010012 S562 10/28/2022
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S806 10/25/2022
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