- Device
- DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S040
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2023-12-14
- Decision code
- APPR
- Date received
- 2023-09-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the Diamondback 360 PrecisionTM Coronary OAD to allow ramping of the speed during GlideAssist.