FDA Registration
Active
🇺🇸 United States
Sphere-9 Catheter
Reg #: 3012520654
·
FEI: 3012520654
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MEDTRONIC, INC.
- Registration Number
- 3012520654
- FEI Number
- 3012520654
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 880 Technology Park Drive
- City
- Billerica
- State
- MA
- ZIP
- 01821
- Country
- US
Regulatory Submissions
- PMA Number
- P240013
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2024-10-25 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2024-10-25 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2024-10-25 |
Proprietary Names
Sphere-9 Catheter
Affera Ablation System
Establishment Types
Manufacture Medical Device