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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.
 
DeviceTMR HOLMIUM LASER SYSTEM
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
ApplicantCryolife, Inc.
1655 Roberts Blvd. NW
Kennesaw, GA 30144
PMA NumberP970029
Supplement NumberS030
Date Received05/25/2016
Decision Date06/23/2016
Product Code MNO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Adding an incoming visual inspection to be conducted after sterilization and before shipping of the laser handpieces.
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