BEUDAMED
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    Tissue Approximation System (TAS)

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

    PIC30

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 11, 2012

    1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIMENSION TPSA CALIBRATOR, MODEL #RC459

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·August 23, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025