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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Classification Namecatheter, coronary, atherectomy
ApplicantCARDIOVASCULAR SYSTEMS, INC.
PMA NumberP130005
Supplement NumberS009
Date Received04/23/2015
Decision Date06/25/2015
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the seal on components of the orbital atherectomy device (oad).
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