PMA P100040S052

Device: Valiant Thoracic Stent Graft with Captivia delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S052
Product code: MIH
Decision date: 2022-10-27
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of visual inspection for a component of the Valiant Thoracic Stent Graft with Captivia Delivery System.

Current openFDA PMA Record#

Device: Valiant Thoracic Stent Graft with Captivia delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S052
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-10-27
Decision code: OK30
Date received: 2022-09-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of visual inspection for a component of the Valiant Thoracic Stent Graft with Captivia Delivery System.