Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
FDA premarket approval P100021/S097 · decided 2021-12-17
Approval details
- PMA number
- P100021
- Supplement
- S097
- Supplement type
- 30-Day Notice
- 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
- 2021-11-17
- Decision date
- 2021-12-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implementation of corrective actions and associated process improvements for all spindle tubing assemblies based on root cause investigation for inadequate welding issue.
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