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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.
 
DeviceCARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantCryolife, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS017
Date Received03/19/2010
Decision Date04/15/2010
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 MODIFICATION OF AN EXISTING WARNING STATEMENT TO STATE: ¿EACH HANDPIECE DELIVERY SYTEM IS SUPPLIED STERILE FOR SINGLE USE ONLY. DO NOT REUSE OR RESTERILIZE. ANY ATTEMPT TO CLEAN AND RESTERILIZE CAN DAMAGE THE FIBEROPTIC.¿
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