|
Device | Zenith® Dissection Endovascular System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | WILLIAM COOK EUROPE APS SANDET 6, DK-4632 BJAEVERSKOV |
PMA Number | P180001 |
Supplement Number | S010 |
Date Received | 11/17/2023 |
Decision Date | 12/15/2023 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement change in the PTFE wire coating of the nitinol release wires used in the introduction system of the Zenith Alpha Thoracic Endovascular Graft and Zenith Dissection Endovascular System |