DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
FDA premarket approval P130005/S031 · decided 2020-12-10
Approval details
- PMA number
- P130005
- Supplement
- S031
- Supplement type
- Special (Immediate Track)
- 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
- 2020-11-13
- Decision date
- 2020-12-10
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Clarifications made to the instructions for use.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.