FDA Registration
Active
🇺🇸 United States
GORE® EXCLUDER® AAA Endoprosthesis
Reg #: 3013164176
·
FEI: 3013164176
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- W. L. Gore & Associates, Inc.
- Registration Number
- 3013164176
- FEI Number
- 3013164176
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2890 De La Cruz Blvd
- City
- Santa Clara
- State
- CA
- ZIP
- 95050
- Country
- US
Regulatory Submissions
- PMA Number
- P020004
Owner / Operator
- Firm Name
- W. L. GORE & ASSOCIATES, INC.
- Operator Number
- 9925013
- Address
- 1505 North Fourth Street
- City
- Flagstaff
- State
- AZ
- Postal Code
- 86004
- Country
- US
- Correspondent
- Lisa Wells
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2007-12-18 |
Proprietary Names
GORE® EXCLUDER® AAA Endoprosthesis
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Establishment Types
Manufacture Medical Device