FDA-Device2013-02-06Class II
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.
Envoy Medical Corporation
Hazard
Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
Sold states
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.
Affected count
44
Manufactured in
5000 Township Parkway, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0750-2013Don't want to check this manually?
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