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FDA PMA

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

PMA编号:P050023 · 2026-09-25

决定日期2026-09-25
PMA 编号P050023
产品代码MRM
设备分类第3类
医疗专科U
咨询委员会CV

器械摘要

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code MRM. It was reviewed by the CV advisory panel.

常见问题

What is the DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Biotronik, Inc..

When did DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER receive FDA 510(k) clearance?

The clearance date for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER can be found in the official FDA records.

Who is the listed applicant for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

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

What is the FDA product code for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

The FDA product code for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is MRM.

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