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FDA PMA

Pump, infusion, implanted, programmable

PMA Number: P080012 · 2025-06-18

ApplicantInfusyn Therapeutics, LLC
Decision Date2025-06-18
PMA NumberP080012
Product CodeLKK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeHO

Device Summary

Pump, infusion, implanted, programmable is the device name listed in this FDA 510(k) record. The listed applicant is Infusyn Therapeutics, LLC. It received FDA 510(k) clearance on 2025-06-18. The device is classified under product code LKK. It was reviewed by the HO advisory panel.

Frequently Asked Questions

What is the Pump, infusion, implanted, programmable?

Pump, infusion, implanted, programmable is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Infusyn Therapeutics, LLC.

When did Pump, infusion, implanted, programmable receive FDA 510(k) clearance?

The clearance date for Pump, infusion, implanted, programmable can be found in the official FDA records.

Who is the listed applicant for Pump, infusion, implanted, programmable?

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

What is the FDA product code for Pump, infusion, implanted, programmable?

The FDA product code for Pump, infusion, implanted, programmable is LKK.

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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