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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DR
MINNEAPOLIS, MN 55211
PMA NumberP130005
Date Received03/15/2013
Decision Date10/21/2013
Product Code MCX 
Docket Number 13M-1363
Notice Date 10/30/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT01092416
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). THE DEVICE IS INDICATED TO FACILITATE STENT DELIVERY IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) WHO ARE ACCEPTABLE CANDIDATES FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) OR STENTING DUE TO DE NOVO, SEVERELY CALCIFIED CORONARY ARTERY LESIONS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S024 
S025 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 
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