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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 Orbital Atherectomy System
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DR
MINNEAPOLIS, MN 55211
PMA NumberP130005
Supplement NumberS017
Date Received03/29/2017
Decision Date08/02/2017
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 for design and material changes to the Saline Line.
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