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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 NumberS003
Date Received05/14/1999
Decision Date11/10/1999
Withdrawal Date 11/06/2020
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new study protocol, having both an accelerated aging and a real time aging arm, to demonstrate a two year shelf life for the TMR Disposable Kit (an accessory for The Heart Laser(TM) System). In addition, approval is requested to extend the shelf life for the TMR Disposable Kit from one year to two years, based on results of the accelerated aging portion of the proposed new protocol.
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