|
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 | S003 |
Date Received | 11/15/2021 |
Decision Date | 12/15/2021 |
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 to the delivery system trigger-wire coating facility and updates to the acceptance criteria used in testing of the trigger wires. |