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U.S. Department of Health and Human Services

Product Classification

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Device agent, bulking, injectable for gastro-urology use
Review Panel Gastroenterology/Urology
Product CodeLNM
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm] 
Third Party Review Not Third Party Eligible
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