PMA P130005S019
- Device
- Diamond Back 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S019
- Product code
- MCX
- Decision date
- 2018-02-09
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for a change in design of the Orbital Atherectomy System Pump (OAS Pump Model SIP-3000).
Current openFDA PMA Record#
- Device
- Diamond Back 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S019
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2018-02-09
- Decision code
- APPR
- Date received
- 2017-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in design of the Orbital Atherectomy System Pump (OAS Pump Model SIP-3000).