Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endur
FDA premarket approval P100021/S072 · decided 2019-03-08
Approval details
- PMA number
- P100021
- Supplement
- S072
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endur
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2018-09-10
- Decision date
- 2019-03-08
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for labeling update to the Endurant Stent Graft IFU as well as the Endurant II/IIs Stent Graft IFU.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.