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FDA PMA

設備,拔除,起搏器電極,經皮

PMA 核准號:P960042 · 2025-12-18

決定日期2025-12-18
PMA 編號P960042
產品代碼MFA
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics (Philips). It received FDA 510(k) clearance on 2025-12-18. The device is classified under product code MFA. It was reviewed by the CV advisory panel.

常見問題

What is the DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS?

DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Spectranetics (Philips).

When did DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS receive FDA 510(k) clearance?

The clearance date for DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS can be found in the official FDA records.

Who is the listed applicant for DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS?

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

What is the FDA product code for DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS?

The FDA product code for DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS is MFA.

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官方來源

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