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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-TM CO2 TMR SYSTEM (THE HEART LASER)
Classification Namesystem, laser, transmyocardial revascularization
Generic Nametransmyocardial revascularization (tmr) device
ApplicantPLC MEDICAL SYSTEMS, INC.
PMA NumberP950015
Supplement NumberS005
Date Received06/28/1999
Decision Date03/08/2000
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for specific software revisions addressed to disarming the laser after it has fired and to resolving a minor y2k problem.
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