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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.
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP970029
Date Received07/02/1997
Decision Date02/11/1999
Product Code
MNO[ Registered Establishments with MNO ]
Docket Number 99M-2238
Notice Date 07/19/1999
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the Eclipse TMR Holmium Laser System. Transmyocardial revascularization with the Eclipse TMR System is indicated for treatment of stable patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium iwth reversible ischemia not amendable to direct coronary revascularization.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S005 S006 S007 S008 S009 S011 S012 
S013 S014 S015 S017 S018 S019 S020 S021 S022 
S024 S025 S026 S027 S028 S029 S030 S032 S033 
S034 S035 S036