PMA P100040S050

Device: Valiant Captivia Stent Graft ith the Captivia Delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S050
Product code: MIH
Decision date: 2021-12-10
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Manufacturing changes to be implemented by the first-tier supplier (Phillips) of stent stop components for the delivery system of Valiant Captivia.

Current openFDA PMA Record#

Device: Valiant Captivia Stent Graft ith the Captivia Delivery System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S050
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-12-10
Decision code: OK30
Date received: 2021-11-30
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 stent stop components for the delivery system of Valiant Captivia.