FDA Registration
Active
🇺🇸 United States
Ovation Stent Graft System
Reg #: 3008011247
·
FEI: 3008011247
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Endologix LLC
- Registration Number
- 3008011247
- FEI Number
- 3008011247
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3910 Brickway Blvd
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
Regulatory Submissions
- PMA Number
- H100008
Owner / Operator
- Firm Name
- Endologix LLC
- Operator Number
- 9034802
- Address
- 2 MUSICK
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Kathryn Simpson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2018-11-14 |
Proprietary Names
Ovation Stent Graft System
Establishment Types
Manufacture Medical Device