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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.
 
DeviceECLIPSE TMR HOLMIUM LASER SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantCRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144
PMA NumberP970029
Supplement NumberS008
Date Received10/05/2001
Decision Date11/29/2001
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN MANUFACTURING LOCATION TO VENTREX, INC. VENTURA, CALIFORNIA.
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