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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 NameHEART LASER(TM) CO2 TMR SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nametransmyocardial revascularization (tmr) device
ApplicantPLC MEDICAL SYSTEMS, INC.
PMA NumberP950015
Supplement NumberS006
Date Received11/24/1999
Decision Date01/11/2000
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplementary product labeling.
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