用于治疗癫痫的植入式脑刺激器
PMA编号:P100026 · 2026-08-19
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决定日期2026-08-19
PMA 编号P100026
产品代码PFN
设备分类第3类
医疗专科U
咨询委员会NE
请注意,您提供的文本“NE”不足以进行翻译,因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本,以便我能够进行准确的翻译。
器械摘要
Implanted brain stimulator for epilepsy is the device name listed in this FDA 510(k) record. The listed applicant is NeuroPace, Inc.. It received FDA 510(k) clearance on 2026-08-19. The device is classified under product code PFN. It was reviewed by the NE advisory panel.
常见问题
What is the Implanted brain stimulator for epilepsy?
Implanted brain stimulator for epilepsy is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is NeuroPace, Inc..
When did Implanted brain stimulator for epilepsy receive FDA 510(k) clearance?
The clearance date for Implanted brain stimulator for epilepsy can be found in the official FDA records.
Who is the listed applicant for Implanted brain stimulator for epilepsy?
The FDA 510(k) record lists NeuroPace, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Implanted brain stimulator for epilepsy?
The FDA product code for Implanted brain stimulator for epilepsy is PFN.
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官方来源
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