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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.
 
DeviceDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCardiovascular Systems, Inc.
651 Campus Dr.
Minneapolis, MN 55211
PMA NumberP130005
Supplement NumberS049
Date Received01/22/2026
Decision Date02/18/2026
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementing duplicate overmold equipment and updating the equipment parameters for the Diamondback 360 and Diamondback 360 Precision Coronary Orbital Atherectomy Device (OAD)
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