PMA P140016S003

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S003
Product code: MIH
Decision date: 2021-07-09
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires.

Current openFDA PMA Record#

Device: Zenith Alpha Thoracic Endovascular Graft
Applicant: Cook Medical Incorporated
PMA number: P140016
Supplement: S003
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2021-07-09
Decision code: OK30
Date received: 2021-06-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires.