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U.S. Department of Health and Human Services

Product Classification
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Device drug coated prostatic dilation catheter for benign prostatic hyperplasia
Definition dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia
Physical State drug-coated balloon catheter
Technical Method exert radial force to dilate narrow prostatic urethra
Target Area prostatic urethra
Review Panel Gastroenterology/Urology
Product CodeQXB
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type PMA
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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