• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device material, embolization, neurovascular, polymerizing or precipitating
Definition This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation.It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ.Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.
Review Panel Neurology
Product CodeNPE
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
-
-