FDA device listing
Ascenda Catheter,Indura 1P Catheter,myPTM Personal Therapy Manager,N'Vision Programmer,N'Vision Software Application…
FDA device listing 1458099229 · Medtronic, Inc.
Key facts
| Proprietary names | Ascenda Catheter,Indura 1P Catheter,myPTM Personal Therapy Manager,N'Vision Programmer,N'Vision Software Application Card,PumpSynchroMed™ Clinician Programmer,SynchroMed® II Clinician Programmer,SynchroMed™ III,SynchroMed II Infusion Pump System,SynchroMed Infusion Pump System |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P860004 |
| Product codes | LKK |
| Device names | LKK - Pump, Infusion, Implanted, Programmable |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LKK |
| Review panels | General Hospital |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC NEUROMODULATION, MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS, MEDTRONIC SOFAMOR DANEK USA, INC. |
| Establishment registrations | 2182207, 3003120897, 3004209178, 3018094310 |
| FEI numbers | 2182207, 3003120897, 3004369318, 3018094310 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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