Diamondback 360 Coronary Orbital Atherectomy System, Diamondback 360 Precision Coronary Orbital Atherectomy System
FDA premarket approval P130005/S046 · decided 2025-04-14
Approval details
- PMA number
- P130005
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Diamondback 360 Coronary Orbital Atherectomy System, Diamondback 360 Precision Coronary Orbital Atherectomy System
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2025-03-28
- Decision date
- 2025-04-14
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- modifying the manufacturing electrical tests (Hi-Pot test) for the Orbital Atherectomy System Pump (OAS Pump) and adding a new functional test for the Hi-Pot tester cord.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.