Diamondback 360 Coronary Orbital Atherectomy Device (OAD)
FDA premarket approval P130005/S016 · decided 2017-05-03
Approval details
- PMA number
- P130005
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Diamondback 360 Coronary Orbital Atherectomy Device (OAD)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2017-03-02
- Decision date
- 2017-05-03
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to revert to manufacturing a previously approved design of the saline pump used as part of CSIs diamondback 360 Orbital Atherectomy System.
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