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U.S. Department of Health and Human Services

Product Classification

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Device catheter, balloon, urethral, drug-coated
Definition Dilate urethral strictures
Physical State Drug-coated balloon catheter
Technical Method Exert radial force to dilate narrow urethral segments (strictures)
Target Area Urethra
Review Panel Gastroenterology/Urology
Product CodeQRH
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible