Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
FDA premarket approval P100021/S125 · decided 2025-05-08
Approval details
- PMA number
- P100021
- Supplement
- S125
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2024-09-30
- Decision date
- 2025-05-08
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for a sterilization site located at BGS Beta-Gamma-Service Gmbh & Co KG located at John-Deere-Str. 3, Bruchsal, Baden-Wurttemberg, 76646, Germany
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