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FDA PMA

alfapump System

PMA Number: P230044 · 2026-05-05

ApplicantSequana Medical NV
Decision Date2026-05-05
PMA NumberP230044
Product CodeSDQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

alfapump System is the device name listed in this FDA 510(k) record. The listed applicant is Sequana Medical NV. It received FDA 510(k) clearance on 2026-05-05. The device is classified under product code SDQ. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the alfapump System?

alfapump System is a medical device that received FDA 510(k) clearance on 2026-05-05. The listed applicant is Sequana Medical NV.

When did alfapump System receive FDA 510(k) clearance?

The clearance date for alfapump System can be found in the official FDA records.

Who is the listed applicant for alfapump System?

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

What is the FDA product code for alfapump System?

The FDA product code for alfapump System is SDQ.

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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