INTENSIA

  • Modelo / Serial
    Product Code: TDF022C, TDF021C, TDF020C
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    INTENSIA Models: VR 124, DR 154, CRT-D 174 || Product Usage: || OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are 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). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

13 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
  • Manufacturer
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