Medtronic CoreValve Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs
FDA premarket approval P100021/S120 · decided 2024-04-10
Approval details
- PMA number
- P100021
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medtronic CoreValve Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2024-03-29
- Decision date
- 2024-04-10
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- internal facility transfer of component extrusion and secondary cutting manufacturing operations
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