Diamondback 360 Precision Coronary Orbital Atherectomy System
FDA premarket approval P130005/S036 · decided 2023-06-01
Approval details
- PMA number
- P130005
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Diamondback 360 Precision Coronary Orbital Atherectomy System
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2022-06-28
- Decision date
- 2023-06-01
- Days to decision
- 338 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a design change to the 1.25mm Coronary Crown Orbital Atherectomy Device, a name change from Diamondback 360 Coronary Orbital Atherectomy System to Diamondback 360 Precision, and updates to the Instructions for Use.
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