PMA P130005S027
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S027
- Product code
- MCX
- Decision date
- 2019-10-09
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for changes to the Orbital Atherectomy Device Component for the Coronary Classic Crown Diamondback 360 Coronary OAS.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S027
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2019-10-09
- Decision code
- APPR
- Date received
- 2019-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the Orbital Atherectomy Device Component for the Coronary Classic Crown Diamondback 360 Coronary OAS.