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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameco2 laser
PMA NumberP950015
Supplement NumberS003
Date Received05/14/1999
Decision Date11/10/1999
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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.