Data / Medical devices / United States / Medtronic, Inc.
Medtronic, Inc.: FDA-registered device maker in Minneapolis, MN, United States, 15 510(k) clearances and 2 PMA approvals
Medtronic, Inc. is registered with the FDA (registration 3015544746) in Minneapolis, MN, United States. It lists 5 device types. The FDA files 15 510(k) clearances and 2 PMA approvals under its listings, the newest dated January 28, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015544746
- Address
- 7000 Central Ave., N.E., Minneapolis, MN, United States, 55432
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- June 24, 2009
- Registered through
- 2026
- Brand names listed
- Ace Header Emulator, DiamondTemp Ablation System, DiamondTemp Ablation Catheter, DiamondTemp Catheter-to-RF Generator Cable, DiamondTemp EGM Cable, DiamondTemp Foot Switch, DiamondTemp GenConnect Cable, DiamondTemp Generator Connection Box E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | 3 | Manufacturer | accessdata.fda.gov |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Pulse-Generator, Pacemaker, External | DTE | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | MXD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2020 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 13, 2020 | K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 8, 2020 | K192636 | TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2020 | K192389 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 30, 2019 | K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| August 21, 2018 | K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| June 7, 2018 | K180122 | TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 24, 2018 | K180030 | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) | FTL | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| April 19, 2018 | K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 12, 2016 | K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| March 27, 2015 | K150291 | TYRX Neuro Absorbable Antibacterial Envelope | FTL | Substantially Equivalent | Medtronic Tyrx, Inc. | accessdata.fda.gov |
| February 18, 2015 | K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 14, 2014 | K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 31, 2013 | K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | DTE | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 20, 2013 | K130943 | AIGIS RX R PM/ AIGIS RX R ICD | FTL | Substantially Equivalent | Tyrx, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 28, 2021 | P200028 | DiamondTemp Ablation System | OAE | 24 | October 10, 2025 | accessdata.fda.gov |
| February 11, 1993 | P900061 | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM | LWS | 170 | April 15, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Pulse-Generator, Pacemaker, External
- All makers of Mesh, Surgical, Polymeric
- All makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
Updated October 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.