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Eclipse TMR Holmium Laser System

by Cryolife, Inc. PMA

Active United States

PMA P970029

Overview

The Eclipse TMR Holmium Laser System is a medical device designed for transmyocardial revascularization (TMR). It uses a holmium laser to create channels in the myocardium to improve blood flow in ischemic heart tissue.

It is indicated for use in stable patients with Canadian Cardiovascular Society Class 4 angina refractory to medical treatment and secondary to coronary artery atherosclerosis with reversible ischemia not amenable to direct revascularization. The system received FDA PMA approval (P970029) and is manufactured by Cryolife, Inc. in Kennesaw, GA.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP970029 Date11 Feb 1999ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Trade Name
Tmr Holmium Laser System
Generic Name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
PMA Number
FDA Product Code
MNO
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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Questions

  • What is the Eclipse TMR Holmium Laser System used for?

    The Eclipse TMR Holmium Laser System is used for transmyocardial revascularization to treat stable patients with refractory angina (Canadian Cardiovascular Society Class 4) due to coronary artery atherosclerosis with reversible ischemia not suitable for direct revascularization, as stated in the approval documentation.

  • Who manufactures the Eclipse TMR Holmium Laser System and where are they located?

    The Eclipse TMR Holmium Laser System is manufactured by Cryolife, Inc., located at 1655 Roberts Blvd. NW, Kennesaw, GA 30144, as specified in the device data.

  • What regulatory authorization does the Eclipse TMR Holmium Laser System have?

    The Eclipse TMR Holmium Laser System has FDA PMA (Premarket Approval) authorization, with PMA number P970029, approved on February 11, 1999, as indicated in the AUTHORIZATIONS and PMA_NUMBER fields.