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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 SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Nameholmium laser system fiber optic delivery system handpiece
ApplicantCRYOLIFE, INC.
PMA NumberP970029
Supplement NumberS026
Date Received04/09/2014
Decision Date05/07/2014
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for including the post approval study labeling changes of the pearl 8. 0 device into the instructions for use of the pearl 5. 0 and the sologrip iii handpieces as well as adding some clarifying statements to ensure the safe handling of the handpieces.
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