FDA-Device2018-09-12Class II
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Inspire Medical Systems Inc.
Hazard
Incorrect use-by date on the device registration/patient file labels.
Sold states
US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.
Affected count
93 devices
Manufactured in
9700 63rd Ave N Ste 200, N/A, Maple Grove, MN, United States
Products
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2969-2018Don't want to check this manually?
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