PMA P130005S028
- Device
- Diamondback 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S028
- Product code
- MCX
- Decision date
- 2020-02-24
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Upgrades to the process controls at the sterilization site.
Current openFDA PMA Record#
- Device
- Diamondback 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S028
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2020-02-24
- Decision code
- OK30
- Date received
- 2020-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrades to the process controls at the sterilization site.