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FDA PMA

heart-valve, non-allograft tissue

PMA Number: P170006 · 2026-07-09

ApplicantMedtronic, Inc.
Decision Date2026-07-09
PMA NumberP170006
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 Medtronic, Inc.. It received FDA 510(k) clearance on 2026-07-09. 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 2026-07-09. The listed applicant is Medtronic, Inc..

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 Medtronic, Inc. 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.

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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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