St. Jude Medical, Cardiology Division, Inc. (manufacturer, Plymouth, MN): 4 new FDA device listings, incl. computer, diagnostic, programmable
St. Jude Medical, Cardiology Division, Inc. (Plymouth, Minnesota): 4 new FDA device listings, incl. computer, diagnostic, programmable. Its amount of 4 is above the median of 2 (83rd percentile). Dated 48 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 4 · 83th percentile of 2,709 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 44 related MN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 83th of 2,709 (median 2, 2.0x median) |
| Peer records CSV (45 MN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: St. Jude Medical, Cardiology Division, Inc. and 45 Minnesota peers
- Minnesota DeviceEstablishmentPulse records like this one: 45
- St. Jude Medical, Cardiology Division, Inc.'s amount: 83rd percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $9,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 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.
What is the DeviceEstablishmentPulse record for St. Jude Medical, Cardiology Division, Inc. in Plymouth, Minnesota?
St. Jude Medical, Cardiology Division, Inc. (Plymouth, MN), a manufacturer, added 4 FDA device listings between 2026-05-21 and 2026-09-18.
How does St. Jude Medical, Cardiology Division, Inc. compare to other Minnesota DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,709 records; the median is 2. It is 48 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
St. Jude Medical, Cardiology Division, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN | 4 | 83rd | 2026-09-18 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Inter-Med, Inc. | Racine, WI | 5 | 86th | 2026-10-22 |
| Centerpoint Systems LLC | West Valley City, UT | 5 | 86th | 2026-10-21 |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Minnesota
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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.