GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
FDA premarket approval P200030/S019 · decided 2025-03-11
Approval details
- PMA number
- P200030
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- W. L. Gore and Associates, Inc.
- Date received
- 2024-09-12
- Decision date
- 2025-03-11
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- Approval of updates to the labeling to reflect the 60-month data from the continued follow-up of subjects enrolled in the AAA 13-03 Short Neck Substudy.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |