- Device
- Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S050
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2026-02-26
- Decision code
- OK30
- Date received
- 2026-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of in-house microbiology product testing site and aligning microbiology product testing frequency to current product testing program