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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 Drive, Suite 401
Nashville, TN 37211
PMA NumberP950015
Supplement NumberS002
Date Received03/29/1999
Decision Date04/27/1999
Withdrawal Date 11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the labeling.
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