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U.S. Department of Health and Human Services

Product Classification
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Device system, intravaginal, for controlled release of drug substance, cder or cber led
Definition Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Physical State Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Technical Method Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Target Area Vagina
Review Panel Obstetrics/Gynecology
Product CodeQLH
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
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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