|
Device | ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | WILLIAM COOK EUROPE APS SANDET 6, DK-4632 BJAEVERSKOV |
PMA Number | P070016 |
Supplement Number | S001 |
Date Received | 06/02/2008 |
Decision Date | 11/26/2008 |
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. |