Gore Excluder Conformable AAA Endoprosthesis (CEXC)
FDA premarket approval P200030 · decided 2020-12-22
Approval details
- PMA number
- P200030
- Trade name
- Gore Excluder Conformable AAA Endoprosthesis (CEXC)
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore and Associates, Inc.
- Date received
- 2020-06-29
- Decision date
- 2020-12-22
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Approval for Gore Excluder Conformable AAA Endoprosthesis (EXCC)This device is indicated to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below:1) Adequate iliac / femoral access;2) Infrarenal aortic neck treatment diameter range of 1632 mm;3) A minimum aortic neck length of 15 mm when proximal aortic neck angulation is =<60 degrees; and4) Iliac artery treatment diameter
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® ENFORM Biomaterial (K222919) | W. L. Gore and Associates, Inc. | 2022-12-19 |
| GORE Tri-Lumen Catheter (K180919) | W. L. Gore and Associates, Inc. | 2018-10-05 |
| GORE Molding and Occlusion Balloon Catheter (K172567) | W. L. Gore and Associates, Inc. | 2018-01-31 |