NZC

Stent, Urethral, Prostatic, Semi-Permanent

产品代码

NZC

器械名称

Stent, Urethral, Prostatic, Semi-Permanent

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。