Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En
FDA premarket approval P100021/S100 · decided 2022-02-07
Approval details
- PMA number
- P100021
- Supplement
- S100
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2022-01-10
- Decision date
- 2022-02-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Removal of a third tier supplier from the manufacturing of Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System and Endurant IIs Stent Graft System.
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