Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C
FDA premarket approval P130005/S025 · decided 2019-04-10
Approval details
- PMA number
- P130005
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2019-02-07
- Decision date
- 2019-04-10
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change to the motor gear material and the addition of a new motor tester.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.