Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf
FDA premarket approval P100021/S091 · decided 2021-05-21
Approval details
- PMA number
- P100021
- Supplement
- S091
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2021-04-23
- Decision date
- 2021-05-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.
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