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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 Nameco2 laser
ApplicantPLC MEDICAL SYSTEMS, INC.
PMA NumberP950015
Supplement NumberS001
Date Received09/21/1998
Decision Date10/06/1998
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post approval clinical study to be conducted as a condition of approval.
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