PMA P100040S046

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S046
Product code: MIH
Decision date: 2021-04-15
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Changing the current pouch sealer with an upgraded pouch sealer.

Current openFDA PMA Record#

Device: Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System
Applicant: Medtronic Vascular
PMA number: P100040
Supplement: S046
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-04-15
Decision code: OK30
Date received: 2021-03-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changing the current pouch sealer with an upgraded pouch sealer.