PMA P130005S025

Device: Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S025
Product code: MCX
Decision date: 2019-04-10
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a change to the motor gear material and the addition of a new motor tester.

Current openFDA PMA Record#

Device: Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S025
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2019-04-10
Decision code: APPR
Date received: 2019-02-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the motor gear material and the addition of a new motor tester.