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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, electrical, implantable, for incontinence
Regulation Description Implanted electrical urinary continence device.
Definition PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeEZW
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 876.5270
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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