Endurant Stent Graft System; Endurant II Stent Graft System; Endurant IIS Stent Graft System
FDA premarket approval P100021/S096 · decided 2021-11-19
Approval details
- PMA number
- P100021
- Supplement
- S096
- Supplement type
- Special (Immediate Track)
- 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
- 2021-10-20
- Decision date
- 2021-11-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the introduction of a proofload test for 100% inspection of the spindle to hypotube bond at Medtronic Galway.
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