Diamondback 360 Coronary Orbital Atherectomy System (OAS)

FDA Premarket Approval P130005 S030

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.

Pre-market Approval Supplement Details

Material and supplier changes to an internal device component

DeviceDiamondback 360 Coronary Orbital Atherectomy System (OAS)
Generic NameCatheter, Coronary, Atherectomy
ApplicantCARDIOVASCULAR SYSTEMS, INC.
Date Received2020-06-17
Decision Date2020-07-15
PMAP130005
SupplementS030
Product CodeMCX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address CARDIOVASCULAR SYSTEMS, INC. 651 Campus Dr minneapolis, MN 55211

Supplemental Filings

Supplement NumberDateSupplement Type
P130005Original Filing
S030 2020-06-17 30-day Notice
S029 2020-03-26 Normal 180 Day Track
S028 2020-01-27 30-day Notice
S027 2019-04-17 Normal 180 Day Track
S026
S025 2019-02-07 Real-time Process
S024 2018-03-15 Real-time Process
S023
S022 2018-02-05 Normal 180 Day Track
S021 2017-12-26 Normal 180 Day Track
S020 2017-08-22 Real-time Process
S019 2017-08-04 Normal 180 Day Track
S018 2017-04-25 Normal 180 Day Track
S017 2017-03-29 Real-time Process
S016 2017-03-02 Real-time Process
S015 2016-11-28 Normal 180 Day Track No User Fee
S014 2016-08-11 Normal 180 Day Track
S013 2016-05-13 30-day Notice
S012 2016-03-23 Normal 180 Day Track
S011 2016-02-19 30-day Notice
S010 2015-12-23 30-day Notice
S009 2015-04-20 Real-time Process
S008 2015-04-10 Real-time Process
S007 2015-02-18 Normal 180 Day Track No User Fee
S006 2015-01-30 Real-time Process
S005 2014-12-18 135 Review Track For 30-day Notice
S004 2014-12-11 135 Review Track For 30-day Notice
S003 2014-09-02 30-day Notice
S002 2014-08-11 Normal 180 Day Track
S001 2014-07-28 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
10850000491363 P130005 000
10850000491356 P130005 000
30852528005705 P130005 021

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