Endurant II/IIs Stent Graft System
FDA premarket approval P100021/S082 · decided 2020-10-21
Approval details
- PMA number
- P100021
- Supplement
- S082
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Endurant II/IIs Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2020-07-24
- Decision date
- 2020-10-21
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the addition of a 146mm limb length configuration to the Endurant II/IIs product size matrix.
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