FDA Registration
Active
🇺🇸 United States
Freezor MAX Surgical cryoablation catheter
Reg #: 2182208
·
FEI: 2182208
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC, INC.
- Registration Number
- 2182208
- FEI Number
- 2182208
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8200 Coral Sea Street NE
- City
- Mounds View
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- PMA Number
- P020045
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 |
|---|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2013-03-28 |
Proprietary Names
Freezor MAX Surgical cryoablation catheter
Cryoconsole
Freezor cardiac cryoablation catheter
Freezor Xtra Surgical cardiac cryoablation catheter
ECG Cable
Freezor Xtra cardiac cryoablation catheter
Coaxial Cable
Nitron Remote
Nitron CryoConsole
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility