PMA P100021S134
- Device
- Endurant™, Endurant™ II/lls Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S134
- Product code
- MIH
- Decision date
- 2026-02-27
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- changes to the e-beam sterilization equipment, and process monitoring at the sterilization contractor
Current openFDA PMA Record#
- Device
- Endurant™, Endurant™ II/lls Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S134
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2026-02-27
- Decision code
- OK30
- Date received
- 2026-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the e-beam sterilization equipment, and process monitoring at the sterilization contractor