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Approval Order.pdf

h210004A.pdf
Preview of Approval order
🔗 Source: accessdata.fda.gov
📊 Size: 173 KB
👤 Author: FDA
⬇️ Downloads: 104

Summary

The FDA has approved a humanitarian device exemption (HDE) application for the NeVa VS, a device used to treat symptomatic cerebral vasospasm in adults. The approval allows for commercial distribution, but with restrictions, including prescription use and specific training for practitioners. The device has an expiration dating of 2 years, and the manufacturer must submit periodic reports and maintain records of facility shipments and IRB oversight. Additionally, the manufacturer must comply with various FDA requirements, including Unique Device Identification (UDI) rule, Medical Device Reporting (MDR) regulation, and recall requirements.

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Description

The FDA has approved a humanitarian device exemption (HDE) application for the NeVa VS, a device used to treat symptomatic cerebral vasospasm in adults.

Technical Information

  • File Format: PDF
  • File Size: 173 KB
  • Pages: 4
  • Language: EN
  • Author: FDA
  • Total Downloads: 104
  • Last Updated: 3 hours ago

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