GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
FDA premarket approval P200030/S018 · decided 2024-09-06
Approval details
- PMA number
- P200030
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2024-08-26
- Decision date
- 2024-09-06
- Days to decision
- 11 days
- Decision code
- OK30
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Phonix, AZ
- Statement
- addition of an automated process for cutting a delivery system component of the GORE EXCLUDER Conformable AAA Endoprosthesis
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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 |