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FDA PMA

系统,血流动力学,植入式

PMA编号:P230040 · 2026-09-25

决定日期2026-09-25
PMA 编号P230040
产品代码MOM
设备分类第3类
医疗专科U
咨询委员会CV

器械摘要

System, hemodynamic, implantable is the device name listed in this FDA 510(k) record. The listed applicant is Endotronix, Inc.. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code MOM. It was reviewed by the CV advisory panel.

常见问题

What is the System, hemodynamic, implantable?

System, hemodynamic, implantable is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Endotronix, Inc..

When did System, hemodynamic, implantable receive FDA 510(k) clearance?

The clearance date for System, hemodynamic, implantable can be found in the official FDA records.

Who is the listed applicant for System, hemodynamic, implantable?

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

What is the FDA product code for System, hemodynamic, implantable?

The FDA product code for System, hemodynamic, implantable is MOM.

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