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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeNZC
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 0 1 0 0

MDR Year MDR Reports MDR Events
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Retention 8 8

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