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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTMR HOLMIUM LASER SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENESIS CORP.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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 
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