Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System,
FDA premarket approval P100021/S114 · decided 2023-06-06
Approval details
- PMA number
- P100021
- Supplement
- S114
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System,
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2023-05-08
- Decision date
- 2023-06-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Addition of alternate suppliers to perform the EtO bioburden reduction process for the Endurant, Endurant II and Endurant IIs Stent Graft System and the Valiant Thoracic Stent Graft with the Captivia Delivery System.
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