PMA P130005S021

Device: Diamondback 360 Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S021
Product code: MCX
Decision date: 2019-09-19
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for inclusion and use of the ViperWire Advance Coronary Guide Wire with Flex Tip with the Diamondback 360 Coronary Orbital Atherectomy System.

Current openFDA PMA Record#

Device: Diamondback 360 Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S021
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2019-09-19
Decision code: APPR
Date received: 2017-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for inclusion and use of the ViperWire Advance Coronary Guide Wire with Flex Tip with the Diamondback 360 Coronary Orbital Atherectomy System.