Devices

Device Recall Angeion Sentinel ICD

  • Modèle / numéro de série
    BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Description du dispositif
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • Manufacturer
    ela Medical Llc
  • 1 Event

Fabricant

ela Medical Llc
  • Adresse du fabricant
    ela Medical Llc, 2950 Xenium Ln N Ste 120, Plymouth MN 55441-2623
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall Angeion Sentinel ICD
  • Modèle / numéro de série
    AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
  • Description du dispositif
    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
  • Manufacturer
    ela Medical Llc