|
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 | S006 |
Date Received | 07/19/2011 |
Decision Date | 12/06/2011 |
Withdrawal Date
|
02/24/2020 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |