DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Catheter, Coronary, Atherectomy

FDA Premarket Approval P130005

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the diamondback 360 coronary orbital atherectomy system (oas). The device is indicated to facilitate stent delivery in patients with coronary artery disease (cad) who are acceptable candidates for percutaneous transluminal coronary angioplasty (ptca) or stenting due to de novo, severely calcified coronary artery lesions.

DeviceDIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Classification NameCatheter, Coronary, Atherectomy
Generic NameCatheter, Coronary, Atherectomy
ApplicantCARDIOVASCULAR SYSTEMS, INC.
Date Received2013-03-15
Decision Date2013-10-21
Notice Date2013-10-30
PMAP130005
SupplementS
Product CodeMCX
Docket Number13M-1363
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address CARDIOVASCULAR SYSTEMS, INC. 651 Campus Dr minneapolis, MN 55211
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P130005Original Filing
S035 2022-02-18 30-day Notice
S034
S033 2021-02-03 Real-time Process
S032 2020-12-18 30-day Notice
S031 2020-11-13 Special (immediate Track)
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
10850026568100 P130005 000
10850026568087 P130005 000
10850026568698 P130005 000
10852528005442 P130005 019
30852528005705 P130005 021

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