用于治疗大便失禁的植入式电设备
PMA编号：P190006 · 2026-08-07
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决定日期2026-08-07
PMA 编号P190006
产品代码QON
设备分类第3类
医疗专科G
法规编号21 CFR 8
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
器械摘要
Implanted electrical device intended for treatment of fecal incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code QON. It was reviewed by the GU advisory panel.
常见问题
What is the Implanted electrical device intended for treatment of fecal incontinence?
Implanted electrical device intended for treatment of fecal incontinence is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Boston Scientific Corporation.
When did Implanted electrical device intended for treatment of fecal incontinence receive FDA 510(k) clearance?
The clearance date for Implanted electrical device intended for treatment of fecal incontinence can be found in the official FDA records.
谁是用于治疗大便失禁的植入式电设备的列名申请人？
FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。
FDA植入式电设备用于治疗大便失禁的产品代码是什么？
FDA产品代码为用于治疗大便失禁的植入式电设备的代码是QON。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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