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FDA PMA

植入式隔神经刺激器,用于治疗中枢性睡眠呼吸暂停

PMA编号:P160039 · 2025-05-07

申请人Respicardia
决定日期2025-05-07
PMA 编号P160039
产品代码PSR
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

Implanted phrenic nerve stimulator for central sleep apnea is the device name listed in this FDA 510(k) record. The listed applicant is Respicardia. It received FDA 510(k) clearance on 2025-05-07. The device is classified under product code PSR. It was reviewed by the AN advisory panel.

常见问题

What is the Implanted phrenic nerve stimulator for central sleep apnea?

Implanted phrenic nerve stimulator for central sleep apnea is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Respicardia.

When did Implanted phrenic nerve stimulator for central sleep apnea receive FDA 510(k) clearance?

The clearance date for Implanted phrenic nerve stimulator for central sleep apnea can be found in the official FDA records.

Who is the listed applicant for Implanted phrenic nerve stimulator for central sleep apnea?

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

What is the FDA product code for Implanted phrenic nerve stimulator for central sleep apnea?

The FDA product code for Implanted phrenic nerve stimulator for central sleep apnea is PSR.

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