FDA Registration
Active
🇺🇸 United States
BOLTON MEDICAL, INC.
Reg #: 2247858
·
FEI: 1000135961
·
Expires 2026
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BOLTON MEDICAL, INC.
- Registration Number
- 2247858
- FEI Number
- 1000135961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 799 International Pkwy
- City
- Sunrise
- State
- FL
- ZIP
- 33325
- Country
- US
Regulatory Submissions
- PMA Number
- P110038
Owner / Operator
- Firm Name
- BOLTON MEDICAL, INC.
- Operator Number
- 9007572
- Address
- 799 INTERNATIONAL PARKWAY, --
- City
- Sunrise
- State
- FL
- Postal Code
- 33325
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | Class 3 | Unknown | No | 2012-12-20 |
Proprietary Names
Relay Thoracic Stent-Graft with Plus Delivery System
RelayPro Thoracic Stent-Graft System
TREO Abdominal Stent-Graft System
TREOFit Template
Relay Thoracic Stent-Graft with Transport Delivery System
TREO AUI Stent-Graft System
TREO Occluder System
Relay NBS Plus Stent -Graft System
Relay Plus Thoracic Stent-Graft System
RelayPro Thoracic Stent Graft System
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only