PMA P130005S031
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S031
- Product code
- MCX
- Decision date
- 2020-12-10
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Clarifications made to the instructions for use.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S031
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2020-12-10
- Decision code
- APPR
- Date received
- 2020-11-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Clarifications made to the instructions for use.