PMA P130005S020
- Device
- Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S020
- Product code
- MCX
- Decision date
- 2017-11-17
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval to extend the product shelf life to 24 months.
Current openFDA PMA Record#
- Device
- Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S020
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2017-11-17
- Decision code
- APPR
- Date received
- 2017-08-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to extend the product shelf life to 24 months.