Endurant, Endurant II and Endurant 11s Stent Graft System
FDA premarket approval P100021/S117 · decided 2023-09-13
Approval details
- PMA number
- P100021
- Supplement
- S117
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endurant, Endurant II and Endurant 11s Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Medtronic Vascular
- Date received
- 2023-08-18
- Decision date
- 2023-09-13
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Implementation of an alternative supplier for the tapered tip components of the Endurant Aortic Delivery System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.