DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
FDA premarket approval P130005/S033 · decided 2021-04-23
Approval details
- PMA number
- P130005
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2021-02-03
- Decision date
- 2021-04-23
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for aminor design change and labeling clarifications.
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