Endurant Stent Graft System
FDA premarket approval P100021/S118 · decided 2023-10-10
Approval details
- PMA number
- P100021
- Supplement
- S118
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2023-09-27
- Decision date
- 2023-10-10
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- implementation of changes in supplier for the Medtronic Valiant Captivia Delivery System and the Endurant Iliac Delivery System and minor manufacturing changes to a component of the Endurant Iliac Delivery System
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