Zenith Dissection Endovascular System
FDA premarket approval P180001 · decided 2018-12-31
Approval details
- PMA number
- P180001
- Trade name
- Zenith Dissection Endovascular System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- William Cook Europe Aps
- Date received
- 2018-01-02
- Decision date
- 2018-12-31
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- 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 indicat
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