FDA-Device2024-09-18Class II
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Medtronic Neuromodulation
Hazard
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Sold states
US Nationwide distribution.
Affected count
211 devices
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3073-2024Don't want to check this manually?
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