FDA device listing
Adapter Cable,Analyzer Adapter,Analyzer Cable,CapSure Lead,CapSure VDD-2 Lead,CardioSight Reader,CareLink Encore…
FDA device listing 2068263149 · Medtronic, Inc.
Key facts
| Proprietary names | 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… |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P890003 |
| Product codes | DXY, KRG, LWP, NKE, NVZ, OSR |
| Device names | DXY - Implantable Pacemaker Pulse-Generator, KRG - Programmer, Pacemaker, LWP - Implantable Pulse Generator, Pacemaker (Non-Crt), NKE - Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), NVZ - Pulse Generator, Permanent, Implantable, OSR - Pacemaker/Icd/Crt Non-Implanted Components |
| Device class | Class III |
| Classification regulations (21 CFR) | 870.3610, 870.3700, ORCA1.LWP, ORCA1.NKE, ORCA1.NVZ, ORCA1.OSR |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), Medtronic Europe Sarl, MEDTRONIC, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA, MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 2182208, 2649622, 9614453, 3003120897, 3009380063, 3018094310 |
| FEI numbers | 2182208, 2649622, 3002807576, 3003120897, 3009380063, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database