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FDA PMA

System, appendage closure, left atrial

PMA Number: P130013 · 2026-08-28

ApplicantBoston Scientific Corp
Decision Date2026-08-28
PMA NumberP130013
Product CodeNGV
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

System, appendage closure, left atrial is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-08-28. The device is classified under product code NGV. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the System, appendage closure, left atrial?

System, appendage closure, left atrial is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Boston Scientific Corp.

When did System, appendage closure, left atrial receive FDA 510(k) clearance?

The clearance date for System, appendage closure, left atrial can be found in the official FDA records.

Who is the listed applicant for System, appendage closure, left atrial?

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

What is the FDA product code for System, appendage closure, left atrial?

The FDA product code for System, appendage closure, left atrial is NGV.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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