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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS024
Date Received01/29/2013
Decision Date05/31/2013
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the distal fibers of the three hand-piece models. The device, as modified, will be marketed under the trade name tmr2000 holmium laser system and is indicated for trans-myocardial revascularization in patients with angina refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.