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U.S. Department of Health and Human Services

Product Classification

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Device agents, embolic, for treatment of benign prostatic hyperplasia
Definition The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Physical State Beads in suspension
Technical Method A catheter is threaded from femoral artery to the prostatic artery and beads are injected until stasis in flow is achieved.
Target Area Prostate
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNOY
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.5550
Device Class 2
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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