PMA P130005S043
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S043
- Product code
- MCX
- Decision date
- 2024-10-28
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- approval for a software change
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S043
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2024-10-28
- Decision code
- APPR
- Date received
- 2024-07-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a software change