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FDA PMA

SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION

PMA Number: P970029 · 2022-09-01

ApplicantCryolife, Inc.
Decision Date2022-09-01
PMA NumberP970029
Product CodeMNO
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Cryolife, Inc.. It received FDA 510(k) clearance on 2022-09-01. The device is classified under product code MNO. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION?

SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Cryolife, Inc..

When did SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION receive FDA 510(k) clearance?

The clearance date for SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION can be found in the official FDA records.

Who is the listed applicant for SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION?

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

What is the FDA product code for SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION?

The FDA product code for SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION is MNO.

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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