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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.
 
Trade NameCARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENESIS CORP.
PMA NumberP970029
Supplement NumberS017
Date Received03/19/2010
Decision Date04/15/2010
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of an existing warning statement to state: ¿each handpiece delivery sytem is supplied sterile for single use only. Do not reuse or resterilize. Any attempt to clean and resterilize can damage the fiberoptic. ¿.
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