|
Device | ZENITH TX2 TAA ENDOVASCULAR GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | WILLIAM COOK EUROPE APS SANDET 6, DK-4632 BJAEVERSKOV |
PMA Number | P070016 |
Supplement Number | S010 |
Date Received | 07/06/2015 |
Decision Date | 08/03/2015 |
Withdrawal Date
|
02/24/2020 |
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 COATING PROCESS PARAMETERS FOR THE RELEASE-WIRES. |