FDA-Device2016-09-14Class II
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Boston Scientific Corporation
Hazard
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
Sold states
Distributed to the states of TX, NH, MA, PA, and MN.
Affected count
5
Manufactured in
4100 Hamline Ave N, Saint Paul, MN, United States
Products
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2749-2016Don't want to check this manually?
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