ENDURANT IIS STENT GRAFT SYSTEM
FDA premarket approval P100021/S039 · decided 2014-10-23
Approval details
- PMA number
- P100021
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDURANT IIS STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2014-07-25
- Decision date
- 2014-10-23
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR THE ADDITION OF FIVE (5) SHORT BIFURCATED STENT GRAFT CONFIGURATIONS TO THE ENDURANT II STENT GRAFT SYSTEM, WHICH ARE CALLED ENDURANT IIS STENT GRAFTS (ALSO REFERRED TO AS ENDURANT IIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ENDURANT IIS STENT GRAFT SYSTEM. THE ENDURANT II/ENDURANT IIS BIFURCATED STENT GRAFTS ARE INDICATED FOR THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS. THE ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.