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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 DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCARDIOVASCULAR SYSTEMS, INC.
651 CAMPUS DR
MINNEAPOLIS, MN 55211
PMA NumberP130005
Supplement NumberS010
Date Received12/23/2015
Decision Date01/21/2016
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
A MANUFACTURING PROCESS CHANGE TO THE JOINING OF THE CROWN TO THE DRIVESHAFT OF THE OAS.
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