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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® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCardiovascular Systems, Inc.
651 Campus Dr.
Minneapolis, MN 55211
PMA NumberP130005
Supplement NumberS045
Date Received03/27/2025
Decision Date04/24/2025
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  
Change to include alternate Tyvek pouch coating material suppliers
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