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U.S. Department of Health and Human Services

Product Classification
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Device device, incontinence, mechanical/hydraulic
Regulation Description Implanted mechanical/hydraulic urinary continence device.
Definition Pma to be filed by 12/26/00 (65 fr 57731 (9/26/00)).
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeEZY
Submission Type PMA
Regulation Number 876.5280
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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