FDA-Device2014-05-07Class II
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
Medtronic Neuromodulation
Hazard
Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
Sold states
Nationwide Distribution - all states including DC and Puerto Rico.
Affected count
170,286 US, 73,921 OUS for all devices
Manufactured in
7000 Central Ave NE, Minneapolis, MN, United States
Products
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2014Don't want to check this manually?
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