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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. NW
Kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS005
Date Received11/09/2000
Decision Date12/08/2000
Product Code MNO 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR TWO SPECIFIC ADDITIONAL QUALITY CONTROL INSPECTION STEPS DURING THE MANUFACTURING OF THE SOLOGRIP HANDPIECE AND THE ADDITION OF SPECIFIC LANGUAGE IN THREE PLACES TO THE INSTRUCTIONS FOR USE FOR THE SOLOGRIP HANDPIECE.
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