DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

Catheter, Coronary, Atherectomy

FDA Premarket Approval P130005 S012

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

Approval to add heat/light stabilizers to the pebax used to construct the saline sheaths of the oad.

• Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Classification Name: Catheter, Coronary, Atherectomy
• Generic Name: Catheter, Coronary, Atherectomy
• Applicant: CARDIOVASCULAR SYSTEMS, INC.
• Date Received: 2016-03-23
• Decision Date: 2016-10-26
• PMA: P130005
• Supplement: S012
• Product Code: MCX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CARDIOVASCULAR SYSTEMS, INC. 651 Campus Dr minneapolis, MN 55211

Supplemental Filings

Supplement Number	Date	Supplement Type
P130005		Original 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 ID	PMA	Supp
10850000491363	P130005	000
10850000491356	P130005	000
10850026568100	P130005	000
10850026568087	P130005	000
10850026568698	P130005	000
10852528005442	P130005	019
30852528005705	P130005	021