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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.
 
DeviceHEART LASER CO2 TMR SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantLaser Engineering Heart Inc.
475 Metroplex Drive, Suite 401
Nashville, TN 37211
PMA NumberP950015
Supplement NumberS012
Date Received10/07/2013
Decision Date07/23/2014
Withdrawal Date 11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHOX, IN BUFFALO, NEW YORK.
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