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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)
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantCardiovascular Systems, Inc.
651 Campus Dr.
Minneapolis, MN 55211
PMA NumberP130005
Supplement NumberS005
Date Received12/18/2014
Decision Date07/07/2015
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF CHANGES TO THE STERILIZATION PROCESS, INCLUDING AN ADDITIONAL STERILIZATION CHAMBER, ALTERNATIVE CONFIGURATIONS FOR PROCESS CHALLENGE DEVICES, REDUCTION IN AERATION TIME, AND ADDITIONAL POST-NITROGEN WASHES AND EVACUATIONS.
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