PAI

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

产品代码

PAI

器械名称

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

管理类别

第 3 类（Class III）

21 CFR 条款

21 CFR 884.5980

FDA 专业组

Obstetrics/Gynecology

上市路径

需 PMA 上市前批准

标记

属植入器械

FDA 历史累计 510(k)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical and uterine prolapse repair completed transvaginally.

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）。