Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
FDA premarket approval P100021/S077 · decided 2020-10-21
Approval details
- PMA number
- P100021
- Supplement
- S077
- Supplement type
- 135 Review Track For 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
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2019-06-06
- Decision date
- 2020-10-21
- Days to decision
- 503 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for a modified wire forming process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.