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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantLaser Engineering Heart, Inc.
475 Metroplex Dr. Suite 401
Nashville, TN 37211
PMA NumberP950015
Date Received04/18/1995
Decision Date08/20/1998
Withdrawal Date11/06/2020
Product Code MNO 
Docket Number 99M-2672
Notice Date 08/17/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for The Heart Laser CO2 TMR System. This device is indicated for the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment and secondary to objectively demonstarted coronary artery atherosclerosis not amenable to direct coronary revascularization.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S007 S008 S010 S011 S012 
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