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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 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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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
Cardiac Resynchronization Therapy Defibrillators (... Boston Scientific Corp. P010012 S573 07/07/2023
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-... Boston Scientific Corp. P010012 S574 07/20/2023
ACUITY™ Spiral, Accessory, Slit Suture Sleeve, ACU... Boston Scientific Corp. P010012 S575 07/21/2023
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INO... Boston Scientific Corp. P010012 S576 10/18/2023
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