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FDA PMA

heart-valve, non-allograft tissue

PMA Number: P040021 · 2026-09-18

ApplicantABBOTT MEDICAL
Decision Date2026-09-18
PMA NumberP040021
Product CodeLWR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

heart-valve, non-allograft tissue is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code LWR. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the heart-valve, non-allograft tissue?

heart-valve, non-allograft tissue is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is ABBOTT MEDICAL.

When did heart-valve, non-allograft tissue receive FDA 510(k) clearance?

The clearance date for heart-valve, non-allograft tissue can be found in the official FDA records.

Who is the listed applicant for heart-valve, non-allograft tissue?

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

What is the FDA product code for heart-valve, non-allograft tissue?

The FDA product code for heart-valve, non-allograft tissue is LWR.

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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