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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 NameTMR2000 HOLMIUM LASER SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENESIS CORP.
PMA NumberP970029
Supplement NumberS011
Date Received05/10/2007
Decision Date11/05/2007
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pearl 5. 0 handpiece.
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