BEUDAMED
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    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.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    OVATIO Models: VR 6250, DR 6550, CRT 6750. 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.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 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.

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·May 24, 2017

    GPI S.P.A.

    Manufacturer
    🇮🇹 Italy·7 Basic UDI-DIs·7 Devices·ITALCERT SRL, BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

    NTC Srl

    Manufacturer
    🇮🇹 Italy·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

    Euleria srl Società Benefit

    Manufacturer
    🇮🇹 Italy·BUREAU VERITAS ITALIA S.P.A., BUREAU VERITAS ITALIA S.P.A., and BUREAU VERITAS ITALIA S.P.A.

    GRUPPO FARMAIMPRESA SRL

    Manufacturer
    🇮🇹 Italy·ITALCERT SRL and ITALCERT SRL

    FRI.MED. S.R.L.

    Manufacturer
    🇮🇹 Italy·TUV Rheinland Italia SRL and TUV Rheinland Italia SRL

    Chiesi Farmaceutici S.p.A.

    Manufacturer
    🇮🇹 Italy·ITALCERT SRL and ITALCERT SRL

    MEDI-LINE S.r.l.

    Manufacturer
    🇮🇹 Italy·12 Basic UDI-DIs·12 Devices·ISTITUTO SUPERIORE DI SANITA' and ISTITUTO SUPERIORE DI SANITA'

    Ascom UMS Srl

    Manufacturer
    🇮🇹 Italy·KIWA CERMET ITALIA S.P.A. and KIWA CERMET ITALIA S.P.A.

    Imaginalis Srl

    Manufacturer
    🇮🇹 Italy·1 Basic UDI-DI·2 Devices·TUV Rheinland Italia SRL

    MEDICAL CONSULTING SRL

    Manufacturer
    🇮🇹 Italy·ITALCERT SRL

    Hydra srl

    Manufacturer
    🇮🇹 Italy·TUV Rheinland Italia SRL

    XENIA REPLY S.r.l.

    Manufacturer
    🇮🇹 Italy·1 Basic UDI-DI·1 Device·ICIM S.P.A.

    PHARMA LINE Srl

    Manufacturer
    🇮🇹 Italy·ITALCERT SRL

    Artsana S.p.A.

    Manufacturer
    🇮🇹 Italy·3 Basic UDI-DIs·3 Devices·ISTITUTO SUPERIORE DI SANITA'

    Eufoton Srl

    Manufacturer
    🇮🇹 Italy·TUV Rheinland Italia SRL

    FB VISION S.p.A.

    Manufacturer
    🇮🇹 Italy·BUREAU VERITAS ITALIA S.P.A.

    Italfarmacia srl

    Manufacturer
    🇮🇹 Italy·ISTITUTO SUPERIORE DI SANITA'