BEUDAMED
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    RUSCH TRACHEAL BRONCHIAL Y STENT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRODIGY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CliniscanSM MRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·February 9, 2013

    ENDOTAK DSP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 10, 2011

    CAPSUREEPI

    FDA Adverse Event
    Death ·MPRI·Product code DTB·July 23, 2014

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017