ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
FDA premarket approval P020018/S040 · decided 2012-04-04
Approval details
- PMA number
- P020018
- Supplement
- S040
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cook, Inc.
- Date received
- 2011-10-07
- Decision date
- 2012-04-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (WITH THE ADJUNCTIVE ZENITH ALIGNMENT STENT). THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OFPATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH REQUIRED INTRODUCTION SYSTEMS;2) NONANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSMS WITH: A) LENGTH >= 4 MM AND UN
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| SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (K133634) | Cook, Inc. | 2013-12-23 |
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