Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
FDA premarket approval P100021/S102 · decided 2022-04-07
Approval details
- PMA number
- P100021
- Supplement
- S102
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2022-03-11
- Decision date
- 2022-04-07
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for implementation of changes to the taper tip manufacturing and inspection processes at the supplier and updates to the inspection plan for the taper tip assembly at Medtronics receiving inspection.
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