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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameNeVa VS
Classification Nametemporary percutaneous transluminal cerebral artery dilatation device
Generic Nametemporary percutaneous transluminal cerebral artery dilatation device
Applicant
Vesalio
2305 historic decatur road, suite 100
san diego,, CA 92106
HDE NumberH210004
Date Received09/20/2021
Decision Date09/09/2022
Product Code
QTK[ Registered Establishments with QTK ]
Docket Number 22M-2197
Notice Date 09/12/2022
Advisory Committee Neurology
Clinical Trials NCT03611790
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Neva vs is indicated for use as an adjunct treatment for symptomatic cerebral vasospasm in the internal carotid artery (ica), middle cerebral artery (mca), anterior cerebral artery (aca), posterior cerebral artery (pca), or basilar artery caused by aneurysmal subarachnoid hemorrhage in adults 22 years of age or older who have exhausted maximal medical treatment and have had the intracranial aneurysm secured by either surgical or endovascular intervention. Symptomatic cerebral vasospasm is defined as more than 50% narrowing of the indicated cerebral vessels confirmed by angiographic imaging and a decreased level of consciousness or focal neurological deficit.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
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