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U.S. Department of Health and Human Services

Product Classification

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Device mesh, surgical, polymeric
Regulation Description Surgical mesh.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeFTL
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch One - Implants and Tools (PRSB1)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • 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] 
  • Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Final
Third Party Review Not Third Party Eligible
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