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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.
 
DeviceHEART LASER 2 (HL2)
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantLaser Engineering Heart Inc.
475 Metroplex Drive, Suite 401
Nashville, TN 37211
PMA NumberP950015
Supplement NumberS008
Date Received09/28/2000
Decision Date01/29/2001
Withdrawal Date 11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING CHANGE TO UP-DATE THE LASER CONSOLE PORTION OF THE DEVICE SYSTEM FROM THE CURRENTLY APPROVED HL1 (HEART LASER(TM)) TO THE HL2 (HEAR LASER 2). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEART LASER 2 (HL2), AND IS INDICATED FOR USE IN THE TREATMENT OF PATIENTS WITH STABLE ANGINA (CANADIAN CARDIOVASCULAR SOCIETY CLASS 3 OR 4) REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION OF THE MYOCARDIUM NOT AMENABLE TO DIRECT CORONARY REVASCULARIZATION.
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