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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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Device
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PMA
Number
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Decision
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CRT-D Resynchronization Devices Boston Scientific Corp. P010012 S548 02/24/2022
Contak CD, Easytrak, Livian, Cognis and Acuity Spi... Boston Scientific Corp. P010012 S550 03/04/2022
ACUITY Spiral Coronary Venous Pace/Sense Lead, ACU... Boston Scientific Corp. P010012 S551 03/08/2022
RESONATE™ HF, RESONATE™, RESONATE™ X4, MOMENTUM™, ... Boston Scientific Corp. P010012 S552 08/26/2022
Tachy DF4 header core Boston Scientific Corp. P010012 S553 04/13/2022
ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/... Boston Scientific Corp. P010012 S554 06/21/2022
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-... Boston Scientific Corp. P010012 S555 07/13/2022
Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-... Boston Scientific Corp. P010012 S556 07/22/2022
ORIGEN CRT-D, ORIGEN X4 CRT-D, INOGEN CRT-D, INOGE... Boston Scientific Corp. P010012 S557 09/27/2022
Bi-Directional Torque Wrench Model 6628 Boston Scientific Corp. P010012 S558 11/15/2022
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