Device Recall Esteem Programmers

  • Modèle / numéro de série
    Lot# EMC0004011 EMC0004665 EMC0004114 EMC0004356 EMC0004639 EMC0004399 EMC0004922 EMC0004923 EMC0004989 EMC0004126 EMC0004310 EMC0004724 EMC0004967 EMC0004759 EMC0004235 EMC0004929 EMC0004234 EMC0004965 EMC0004932 EMC0004928 EMC0004969 EMC0004930 EMC0004844 EMC0004053   Lot# EMC0003968 EMC0003985 EMC0003935 EMC0004028 EMC0004027 EMC0004376 EMC0004125 EMC0004303 EMC0004196 EMC0003852 EMC0004191 EMC0004286 EMC0004491 EMC0004594 EMC0004757 EMC0004510   Lot# EMC0004304 EMC0004797    Lot# EMC0003827 EMC0004233
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.
  • Description du dispositif
    Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. || The ISA and Commander are software packages that run on a laptop personal computer.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Envoy Medical Corporation, 5000 Township Parkway, Saint Paul MN 55110
  • Société-mère du fabricant (2017)
  • Source
    USFDA