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FDA PMA

膈/横膈神经腹腔镜植入式刺激器

PMA编号:P200018 · 2023-03-31

决定日期2023-03-31
PMA 编号P200018
产品代码OIR
设备分类第3类
医疗专科U
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。

器械摘要

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Synapse Biomedical, Inc.. It received FDA 510(k) clearance on 2023-03-31. The device is classified under product code OIR. It was reviewed by the AN advisory panel.

常见问题

What is the diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Synapse Biomedical, Inc..

When did diaphragmatic/phrenic nerve laparoscopically-implanted stimulator receive FDA 510(k) clearance?

The clearance date for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator can be found in the official FDA records.

Who is the listed applicant for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

The FDA 510(k) record lists Synapse Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator?

The FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator is OIR.

相关临床试验

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官方来源

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