DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)

FDA Premarket Approval P130005 S029

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

Performing certain manufacturing processes for the 1. 25mm classic crown oad assembly internally

DeviceDIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
Generic NameCatheter, Coronary, Atherectomy
ApplicantCARDIOVASCULAR SYSTEMS, INC.
Date Received2020-03-26
Decision Date2020-06-18
PMAP130005
SupplementS029
Product CodeMCX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
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
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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