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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
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 876.5280
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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