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FDA PMA

HEART-VALVE, MECHANICAL

PMA Number: P990046 · 2023-11-07

ApplicantMedtronic Ats Medical, Inc.
Decision Date2023-11-07
PMA NumberP990046
Product CodeLWQ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

HEART-VALVE, MECHANICAL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Ats Medical, Inc.. It received FDA 510(k) clearance on 2023-11-07. The device is classified under product code LWQ. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the HEART-VALVE, MECHANICAL?

HEART-VALVE, MECHANICAL is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Medtronic Ats Medical, Inc..

When did HEART-VALVE, MECHANICAL receive FDA 510(k) clearance?

The clearance date for HEART-VALVE, MECHANICAL can be found in the official FDA records.

Who is the listed applicant for HEART-VALVE, MECHANICAL?

The FDA 510(k) record lists Medtronic Ats Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART-VALVE, MECHANICAL?

The FDA product code for HEART-VALVE, MECHANICAL is LWQ.

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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