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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS022
Date Received10/19/2012
Decision Date12/18/2012
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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