PMA P100040S045

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System and Valiant T
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S045
Product code: MIH
Decision date: 2021-03-12
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.

Current openFDA PMA Record#

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System and Valiant T
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S045
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-03-12
Decision code: OK30
Date received: 2021-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of new product label and component verification software for use on manufacturing lines in Medtronic Ireland.