Product Classification

• Device: agents, embolic, for treatment of benign prostatic hyperplasia
• Regulation Description: Prostatic artery embolization device.
• 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 Code: NOY
• Premarket Review: Office of 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

Guidance Document

• Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible