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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTHE HEART LASER CO2 TMR SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nametransmyocardial revascularization (tmr) device
ApplicantNOVADAQ TECHNOLOGIES, INC.
PMA NumberP950015
Supplement NumberS011
Date Received09/12/2008
Decision Date03/08/2009
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes made to the labeling as a result of completion of the post-approval study.
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