- Device
- DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S042
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2024-05-02
- Decision code
- APPR
- Date received
- 2024-03-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing site located at Cardiovascular Systems Incorporated, 14740 Kirby Dr, Houston, TX 77047 for coronary driveshaft, crown, and Precision manufacturing operations