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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, vaginal, muscle, powered, for therapeutic use
Regulation Description Powered vaginal muscle stimulator for therapeutic use.
Definition Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeHII
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
Regulation Number 884.5940
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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