device pma

Boston Scientific — ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33 (PMA supplement)

July 11, 2025$BSXupdated 2mo ago

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Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR

Boston Scientific — ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33 (PMA supplement)