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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 NameTHE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameco2 laser
ApplicantNOVADAQ CORP.
PMA NumberP950015
Date Received04/18/1995
Decision Date08/20/1998
Product Code
MNO[ Registered Establishments with MNO ]
Docket Number 99M-2672
Notice Date 08/17/1999
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 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 Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 S010 S011 
S012 
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