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FDA PMA

內置式橫隔膜神經刺激器,用於治療中樞性睡眠呼吸中止症

PMA 核准號:P160039 · 2025-05-07

申請人Respicardia
決定日期2025-05-07
PMA 編號P160039
產品代碼PSR
器械分類3 類
醫療專科U
諮詢委員會AN

器材摘要

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.

常見問題

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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官方來源

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