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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 37 Results
productcode MHY PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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Deep Brain Stimulation (DBS) System Abbott Medical P140009 S073 12/30/2021
Activa® Deep Brain Stimulation Therapy System, Per... MEDTRONIC Inc. P960009 S414 12/15/2021
Activa Deep Brain Stimulation Therapy System, Perc... MEDTRONIC Inc. P960009 S413 12/03/2021
SenSight Burr Hole Device, SenSight Burr Hole Devi... MEDTRONIC Inc. P960009 S411 11/19/2021
Infinity DBS IPG Abbott Medical P140009 S074 11/16/2021
Activa® Deep Brain Stimulation Therapy System; Per... MEDTRONIC Inc. P960009 S412 11/05/2021
SenSight™ Extension Kit MEDTRONIC Inc. P960009 S410 10/27/2021
Vercise PC, Vercise Gevia and Vercise Genus DBS Sy... Boston Scientific Corp. P150031 S040 10/20/2021
Infinity Deep Brain Stimulation (DBS) Implantable ... Abbott Medical P140009 S071 09/27/2021
SenSight™ Directional Lead Kit MEDTRONIC Inc. P960009 S407 09/09/2021
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