ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
FDA premarket approval P140016 · decided 2015-09-15
Approval details
- PMA number
- P140016
- Trade name
- ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook Medical Incorporated
- Date received
- 2014-08-13
- Decision date
- 2015-09-15
- Days to decision
- 398 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bjaeverskov
- Statement
- APPROVAL FOR THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ISOLATED LESIONS OF THE DESCENDING THORACIC AORTA (NOT INCLUDING DISSECTIONS) HAVING VASCULAR ANATOMY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ILIAC/FEMORAL ANATOMY THAT IS SUITABLE FOR ACCESS WITH THE REQUIRED INTRODUCTION SYSTEMS; AND2) NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC LESION:A) WITH A LENGTH OF AT LEAST 20 M
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