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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 NumberS002
Date Received08/11/2014
Decision Date02/12/2015
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THE DESIGN OF THE ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP MODEL SIP-3000) INCLUDING THE ADDITION OF A SECONDARY MOTOR FEEDBACK PRINTED CIRCUIT BOARD, THE ADDITION OF A SHROUD OVER THE AC POWER CORD CONNECTION, THE ADDITION OF A 100% INSPECTION OF POWER JACK RETENTION, AND THE SELECTION OF AN ALTERNATE VENDOR FOR THE TIMER COMPONENT.
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