Endurant Stent Graft Family
FDA premarket approval P100021/S092 · decided 2021-05-28
Approval details
- PMA number
- P100021
- Supplement
- S092
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Endurant Stent Graft Family
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2021-04-28
- Decision date
- 2021-05-28
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to provide supplemental data from the ANCHOR Registry from an additional 60 subjects treated for short neck infrarenal aneurysms to provide support long-term safety and effectiveness data on the short neck indication
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