ENDURANT II AUI STENT GRAFT SYSTEM
FDA premarket approval P100021/S021 · decided 2013-04-16
Approval details
- PMA number
- P100021
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDURANT II AUI STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2012-10-11
- Decision date
- 2013-04-16
- Days to decision
- 187 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM, A LINE EXTENSION TO THE CURRENT ENDURANT II STENT GRAFT SYSTEM. THE DEVICE, AS MODIFIED, WILL BEMARKETED UNDER THE TRADE NAME ENDURANT II STENT GRAFT SYSTEM. THE ENDURANT II BIFURCATED STENTGRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT IS INDICATED FOR THE ENDOVASCULARTREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOI
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