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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 TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENESIS CORP.
PMA NumberP970029
Supplement NumberS021
Date Received08/16/2012
Decision Date09/13/2012
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 changes to the instructions for use to clarify the device description, warnings, adverse effects and device operating instructions.
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