PMA P100040S048

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S048
Product code: MIH
Decision date: 2021-08-05
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.

Current openFDA PMA Record#

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S048
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-08-05
Decision code: OK30
Date received: 2021-07-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing changes to be implemented by the first-tier supplier (Phillips) of components for the delivery systems of Valiant Captivia and Endurant series devices.