Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
FDA premarket approval P100021/S129 · decided 2025-09-15
Approval details
- PMA number
- P100021
- Supplement
- S129
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2025-03-31
- Decision date
- 2025-09-15
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to remove a warning from the device labeling regarding lack of safety and effectiveness data on the use of your device in emergency treatment of aneurysms, as well as a brief summary of the supportive data with regard to treatment of ruptured aneurysms.
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