Devices

Device Recall enpath Myopore Bipolar 54 cm Epicardial Lead Sutureless Myocardial Pacing Lead

  • Modelo / Serial
    serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: to USA and Europe, through distributor in MN.
  • Descripción del producto
    enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
  • Manufacturer
    Greatbatch Medical
  • 1 Event

Fabricante

Greatbatch Medical
  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
  • Empresa matriz del fabricante (2017)
    Integer Holdings Corporation
  • Source
    USFDA