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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 (OAS) Micro Crown Orbital Atherectomy Device (OAD)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DR
MINNEAPOLIS, MN 55211
PMA NumberP130005
Supplement NumberS020
Date Received08/22/2017
Decision Date11/17/2017
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval to extend the product shelf life to 24 months.
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