FDA Registration
Active
🇺🇸 United States
TREO Occluder System
Reg #: 2247858
·
FEI: 1000135961
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BOLTON MEDICAL, INC.
- Registration Number
- 2247858
- FEI Number
- 1000135961
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 799 International Pkwy
- City
- Sunrise
- State
- FL
- ZIP
- 33325
- Country
- US
Owner / Operator
- Firm Name
- BOLTON MEDICAL, INC.
- Operator Number
- 9007572
- Address
- 799 INTERNATIONAL PARKWAY, --
- City
- Sunrise
- State
- FL
- Postal Code
- 33325
- Country
- US
- Correspondent
- Megan A Indeglia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2007-11-21 |
Proprietary Names
TREO Occluder System
Relay Thoracic Stent-Graft with Transport Delivery System
TREO Abdominal Stent-Graft System
TREO AUI Stent-Graft System
Relay Plus Thoracic Stent-Graft System
Relay NBS Plus Stent -Graft System
RelayPro Thoracic Stent Graft System
Establishment Types
Manufacture Device in the United States for Export Only