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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
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS001
Date Received03/26/1999
Decision Date09/17/1999
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a proposed post-approval study protocol. In addition, all advertising and promotional materials must include the warning aobut the use of TMR in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device.
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