PMA P130005S017
- Device
- DIAMONDBACK 360 Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S017
- Product code
- MCX
- Decision date
- 2017-08-02
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for design and material changes to the Saline Line.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S017
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2017-08-02
- Decision code
- APPR
- Date received
- 2017-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and material changes to the Saline Line.