FDA PMA

Mitral valve repair devices

PMA Number: P100009 · 2026-06-25

ApplicantABBOTT MEDICAL

Decision Date2026-06-25

PMA NumberP100009

Product CodeNKM

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

Mitral valve repair devices is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-06-25. The device is classified under product code NKM. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Mitral valve repair devices?

Mitral valve repair devices is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is ABBOTT MEDICAL.

When did Mitral valve repair devices receive FDA 510(k) clearance?

The clearance date for Mitral valve repair devices can be found in the official FDA records.

Who is the listed applicant for Mitral valve repair devices?

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 Mitral valve repair devices?

The FDA product code for Mitral valve repair devices is NKM.

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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.