DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown
FDA premarket approval P130005/S018 · decided 2017-10-20
Approval details
- PMA number
- P130005
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) Classic Crown
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2017-04-25
- Decision date
- 2017-10-20
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of a software change to implement a feature referred to as GlideAssist.
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