FDA Registration
Active
🇺🇸 United States
Medtronic, Inc.
Reg #: 3015544746
·
FEI: 3015544746
·
Expires 2026
Products
5
Proprietary Names
35
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Medtronic, Inc.
- Registration Number
- 3015544746
- FEI Number
- 3015544746
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7000 Central Ave., N.E.
- City
- Minneapolis
- State
- MN
- ZIP
- 55432
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190825
- PMA Number
- P900061
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 |
|---|---|---|---|---|---|
| Pulse-Generator, Pacemaker, External | DTE | Class 2 | Cardiovascular | No | 2019-07-03 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2021-04-05 |
| Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | MXD | Class 2 | Cardiovascular | No | 2020-07-08 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2009-06-24 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2021-06-09 |
Proprietary Names
External Pulse Generator
EPG Cover
External Pacemaker Pulse Generator
TYRX Neuro Absorbable Antibacterial Envelope
LINQ Tool Kit
LINQ II Insertable Cardiac Monitor
Medtronic Temporary External Pacemaker
TYRX Absorbable Antibacterial Envelope
TYRX Absorbable Antibacterial Envelope
Reveal LINQ Insertion Tools
REVEAL LINQ
PCD
End Cap
GEM
Patient Cable
Lead Patch
MICRO JEWEL
Patient Magnet
MICRO JEWEL II
Ace Header Emulator
Epicardial Patch Lead
Upsizing Sleeve
Sizing Sleeve
GEM VR
DiamondTemp Generator Connection Box E
DiamondTemp RF Generator
DiamondTemp EGM Cable
DiamondTemp GenConnect Cable
DiamondTemp Irrigation Tubing Set
DiamondTemp Ablation System
DiamondTemp Catheter-to-RF Generator Cable
DiamondTemp Irrigation Pump
DiamondTemp Ablation Catheter
DiamondTemp Foot Switch
TYRX Neuro Absorbable Antibacterial Envelope
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only