DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
FDA premarket approval P130005/S029 · decided 2020-06-18
Approval details
- PMA number
- P130005
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2020-03-26
- Decision date
- 2020-06-18
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for performing certain manufacturing processes for the 1.25mm Classic Crown OAD assembly internally.
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