2 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Italy
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DDK ITALIA S.r.l.
Manufacturer
🇮🇹 Italy
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
FDA Enforcement
Class II
·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017