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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 40 of 58 Results
productcode NIK PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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PMA
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Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S840 11/29/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S841 12/13/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S842 12/15/2023
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT... MEDTRONIC CARDIAC RHYTHM DISEA P010031 S843 12/10/2023
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN,... Boston Scientific Corp. P010012 S567 04/21/2023
NG3 Cardiac Resynchronization Therapy Defibrillato... Boston Scientific Corp. P010012 S568 05/11/2023
Level VIII Controlled Environment Area (CEA), Leve... Boston Scientific Corp. P010012 S569 05/01/2023
Multicenter Automatic Defibrillator Implantation T... Boston Scientific Corp. P010012 S570 10/19/2023
HeartLogic™ Boston Scientific Corp. P010012 S571 11/15/2023
ACUITY™ Spiral, ACUITY™ X4 Straight, ACUITY™ X4 Sp... Boston Scientific Corp. P010012 S572 07/06/2023
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