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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 NumberS005
Date Received12/18/2014
Decision Date07/07/2015
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
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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