Endurant II/IIs Stent Graft System
FDA premarket approval P100021/S063 · decided 2017-09-29
Approval details
- PMA number
- P100021
- Supplement
- S063
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Endurant II/IIs Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2017-04-03
- Decision date
- 2017-09-29
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the expansion of the indications for use of the Endurant II/Endurant IIs Stent Graft System to include the treatment of infrarenal abdominal aortic aneurysms having neck lengths >= 4 mm and < 10 mm (short necks), when used in conjunction with the Heli-FX EndoAnchor System. The Endurant II/Endurant IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX Endo
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