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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
Applicant
CRYOLIFE, INC.
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.
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