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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 NameSOLARGEN 2100S LASER
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENESIS CORP.
PMA NumberP970029
Supplement NumberS009
Date Received04/05/2004
Decision Date12/23/2004
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the solargen 2100s laser to replace the tmr2000 laser in the cardiogenesis tmr holmium laser system. The solargen 2100s will be manufactured by new star lasers, inc. Of roseville, california.
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