FDA-Device2021-04-28Class II
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
BIOTRONIK Inc
Hazard
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Sold states
US: Nationwide OUS: Worldwide
Affected count
323 UNITS
Manufactured in
6024 Jean Rd, N/A, Lake Oswego, OR, United States
Products
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2021Don't want to check this manually?
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