PMA P140016S002

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S002
Product code: MIH
Decision date: 2021-04-27
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for labeling update which incorporates the final 5-year results from the post-approval study for continued follow-up of pivotal and continued access patients enrolled in the premarket study.

Current openFDA PMA Record#

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S002
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-04-27
Decision code: APPR
Date received: 2020-10-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for labeling update which incorporates the final 5-year results from the post-approval study for continued follow-up of pivotal and continued access patients enrolled in the premarket study.