PMA P100021S098
- Device
- Endurant Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S098
- Product code
- MIH
- Decision date
- 2021-12-20
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- Add a verification fixture to ensure use of the correct stent stop assembly size in the manufacturing of the Endurant Stent Graft System.
Current openFDA PMA Record#
- Device
- Endurant Stent Graft System
- Applicant
- Medtronic Vascular
- PMA number
- P100021
- Supplement
- S098
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2021-12-20
- Decision code
- OK30
- Date received
- 2021-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a verification fixture to ensure use of the correct stent stop assembly size in the manufacturing of the Endurant Stent Graft System.