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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 CO2 TMR SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantLaser Engineering Heart, Inc.
475 Metroplex Dr. Suite 401
Nashville, TN 37211
PMA NumberP950015
Supplement NumberS011
Date Received09/12/2008
Decision Date03/08/2009
Withdrawal Date11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES MADE TO THE LABELING AS A RESULT OF COMPLETION OF THE POST-APPROVAL STUDY.
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