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FDA PMA

Heart-valve, polymeric

PMA Number: P260007 · 2026-10-01

ApplicantEdwards Lifesciences, LLC
Decision Date2026-10-01
PMA NumberP260007
Product CodeSJL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Heart-valve, polymeric is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-10-01. The device is classified under product code SJL. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Heart-valve, polymeric?

Heart-valve, polymeric is a medical device that received FDA 510(k) clearance on 2026-10-01. The listed applicant is Edwards Lifesciences, LLC.

When did Heart-valve, polymeric receive FDA 510(k) clearance?

The clearance date for Heart-valve, polymeric can be found in the official FDA records.

Who is the listed applicant for Heart-valve, polymeric?

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

What is the FDA product code for Heart-valve, polymeric?

The FDA product code for Heart-valve, polymeric is SJL.

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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