FDA Registration
Active
🇸🇬 Singapore
Revo MRI SureScan
Reg #: 3008973940
·
FEI: 3008973940
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Medtronic Singapore Operations Pte Ltd
- Registration Number
- 3008973940
- FEI Number
- 3008973940
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 49 Changi South Avenue 2, Nasaco Tech Centre
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- PMA Number
- P090013
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 |
|---|---|---|---|---|---|
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2011-02-10 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2011-02-10 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2011-02-10 |
Proprietary Names
Revo MRI SureScan
CapSureFix MRI SureScan Lead
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device