Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf
FDA premarket approval P100021/S094 · decided 2021-08-05
Approval details
- PMA number
- P100021
- Supplement
- S094
- 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, Endurant II AUI Stent Graf
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2021-07-27
- Decision date
- 2021-08-05
- Days to decision
- 9 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.
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