FDA device listing
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FDA device listing 1991560562 · Medtronic, Inc.
Key facts
| Proprietary names | Attain Ability Lead,Attain Ability MRI SureScan Lead,Attain Ability Plus Lead,Attain Ability Plus MRI SureScan Lead,Attain Ability Straight Lead,Attain Ability Straight MRI SureScan Lead,Attain Performa Lead,Attain Performa MRI SureScan Lead,Attain Performa S Lead,Attain Performa S MRI SureScan Lead,Attain Performa Straight Lead,Attain Performa Straight MRI SureScan Lead,Attain Stability Quad MRI… |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | P080006 |
| Product codes | OJX |
| Device names | OJX - Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OJX |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic Distribution Center, Medtronic Engineering and Innovation Center (MEIC), MEDTRONIC, INC., MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA |
| Establishment registrations | 2182208, 2649622, 3009380063, 3018094310 |
| FEI numbers | 2182208, 2649622, 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
- 10–99 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