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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
Classification Namesystem, laser, transmyocardial revascularization
Generic Nametransmyocardial revascularization (tmr) device
ApplicantPLC MEDICAL SYSTEMS, INC.
PMA NumberP950015
Supplement NumberS007
Date Received09/12/2000
Decision Date09/27/2000
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the existing post-approval study to no longer require study enrollment at new sites, and to limit study participation to those (existing) sites which have enrolled patients.
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