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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BOSTONSCIENTIFIC productcode LWP Decision Date To 05/22/2024
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PMA
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Essentio MRI SR, Essentio MRI DR, Essentio MRI EL ... BOSTONSCIENTIFIC P150012 S087 12/04/2019
Essentio MRI SR/DR SL, Essentio MRI DR EL, Propone... BOSTONSCIENTIFIC P150012 S086 11/27/2019
MRI Pacemakers BOSTONSCIENTIFIC P150012 S084 10/29/2019
Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMI... BOSTONSCIENTIFIC P150012 S081 10/18/2019
Essentio, Proponent, and Accolade MRI Pacemakers BOSTONSCIENTIFIC P150012 S082 09/24/2019
Essentio, Proponent, and Accolade MRI Pacemakers BOSTONSCIENTIFIC P150012 S080 09/18/2019
Ingevity MRI Leads and Slit Suture Sleeve Accessor... BOSTONSCIENTIFIC P150012 S078 07/31/2019
Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMI... BOSTONSCIENTIFIC P150012 S073 07/08/2019
INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI... BOSTONSCIENTIFIC P150012 S076 07/08/2019
Accolade MRI Pacemakers BOSTONSCIENTIFIC P150012 S079 06/21/2019
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