DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS)
FDA premarket approval P130005/S042 · decided 2024-05-02
Approval details
- PMA number
- P130005
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Cardiovascular Systems, Inc.
- Date received
- 2024-03-07
- Decision date
- 2024-05-02
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- a manufacturing site located at Cardiovascular Systems Incorporated, 14740 Kirby Dr, Houston, TX 77047 for coronary driveshaft, crown, and Precision manufacturing operations
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