2 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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).
FDA Recall
Terminated
·Inspire Medical Systems Inc.·Product code MNQ·June 12, 2018
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).
FDA Enforcement
Class II
·Terminated·Inspire Medical Systems Inc.·September 12, 2018