| Proprietary Name: |
Adapter Cable; Analyzer Adapter; Analyzer Cable; CapSure Lead; CapSure VDD-2 Lead; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Programmer RF Head; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application iOS; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSync PSA Application; CareLink Wireless Network Adapter Card; ECG Cable; ECG Output Adapter; ECG Port Plug; Instrument Command Library (ICL)Device Command Library (DCL); Integrated Diagnostics Data Calculation Module Model 5242; Lead Analyzer; Medtronic CareLink Monitor; Medtronic CareLink Programmer; MyCareLink Patient Monitor; Prodigy IPG; Program Interface Cable; Service Kit; Sterile Plastic Sleeve |
| Classification Name: |
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
| Product Code: |
NKE |
| Device Class: |
3 |
| Registered Establishment Name: |
Medtronic Europe Sarl
|
| Registered Establishment Number: |
9614453
|
| Premarket Submission Number: |
P890003 |
| Owner/Operator: |
Medtronic, Inc. |
| Owner/Operator Number: |
2112641
|
| Establishment Operations: |
Manufacturer
|
