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U.S. Department of Health and Human Services

Product Classification
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Device mechanical compression device fecal incontinence (non-manually operated)
Definition For treatment of fecal incontinence in patients who have failed conservative therapies
Physical State The device is comprised of an annular ring (implant), sizing tool and insertion tool.
Technical Method Compresseion of the anal sphincter through use of magnetic force
Target Area External anal sphincter.
Review Panel Gastroenterology/Urology
Product CodePMH
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
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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