Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
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 OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
-
-