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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHE HEART LASER(TM)CO2 TMR SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantLaser Engineering Heart, Inc.
475 Metroplex Dr. Suite 401
Nashville, TN 37211
PMA NumberP950015
Supplement NumberS007
Date Received09/12/2000
Decision Date09/27/2000
Withdrawal Date11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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