# St. Jude Medical, Cardiology Division, Inc. (manufacturer, Plymouth, MN): 4 new FDA device listings, incl. computer, diagnostic, programmable

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | St. Jude Medical, Cardiology Division, Inc. |
| Owner / operator | Abbott Laboratories |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Device in the United States for Export Only |
| Location | Plymouth, MN, US |
| New listings | 4 |
| Devices | Computer, Diagnostic, Programmable; System, Appendage Closure, Left Atrial |
| Product codes | DQK, NGV |
| Device classes | Class II, Class III |
| Medical specialties | Cardiovascular |
| Brand names | EnSite™ X EP System, TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, Software License; EnSite™ X EP System, Software Upgrade; EnSite™ X EP System, TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ Temporary, Software License; EnSite™ X EP System, PFA Index Temporary, Software License; EnSite™ X EP System, PFA Index, Software License; Amulet™ 360 Left Atrial Appendage Occluder; EnSite™ X EP System EnSite™ AI Geo Temporary Software License; EnSite™ X EP System EnSite™ AI Geo Software License |
| First new listing | 2026-05-21 |
| Latest new listing | 2026-09-18 |
| FDA registration number | 3005334138 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.