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U.S. Department of Health and Human Services

Product Classification

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Device agents,embolic,for treatment of uterine fibroids
Regulation Description Vascular embolization device.
Regulation Medical Specialty Cardiovascular
Review Panel Obstetrics/Gynecology
Product CodeNAJ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 870.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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