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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 |
Date Received | 01/02/2018 |
Decision Date | 12/31/2018 |
Product Code |
MIH |
Docket Number | 19M-0028 |
Notice Date | 01/25/2019 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01568320
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal the entry tear(s) and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having suitable vascular anatomy for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems; for the Zenith TX2 Dissection Endovascular Graft with Pro-Form: non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm for the graft, and non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm for the graft; for the Zenith Dissection Endovascular Stent: diameter at non-aneurysmal intended implant site for the stent (measured outer-wall to outer- wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 S013 S014 |