Diamond Back 360 Coronary Orbital Atherectomy System
FDA premarket approval P130005/S019 · decided 2018-02-09
Approval details
- PMA number
- P130005
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Diamond Back 360 Coronary Orbital Atherectomy System
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2017-08-04
- Decision date
- 2018-02-09
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a change in design of the Orbital Atherectomy System Pump (OAS Pump Model SIP-3000).
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