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U.S. Department of Health and Human Services

Product Classification

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Device stent, urethral, prostatic, semi-permanent
Definition Approximately 3 cm tube placed in the prostatic urethra for short term use to drain urine. The device includes a retention mechanism that anchors in the bladder neck to hold it in place and a release mechanism that exits the penis. For short term use in men with partial of full prostatic urethral obstruction or the prevention of prostatic urethral obstruction post surgery or other prostatic treatment.
Physical State Approximately 3 centimeter tube (i.e. length of prostatic urethra) that is inserted into the prostatic urethra and includes a proximal retention component that anchors the device in the bladder neck and a suture-type material on the distal end that exits the urethra.
Technical Method The urethral stent crosses a partially or fully obstructed prostatic urethra to allow passage of urine.
Target Area Prostatic urethra.
Review Panel Gastroenterology/Urology
Product CodeNZC
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible