FDA Device Registration & Listing · Jackson, MN, US · Registration 2135338
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | Class 3 | N/A | 2014-05-16 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | Unknown | Class 3 | N/A | 2014-04-29 |
| LKK | Pump, Infusion, Implanted, Programmable | Unknown | Class 3 | N/A | 2012-11-29 |
| MVK | Wearable Automated External Defibrillator | Unknown | Class 3 | N/A | 2025-07-07 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2015-02-05 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | Class 2 | 882.5870 | 2015-02-05 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2015-02-05 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | Class 3 | N/A | 2012-11-29 |
| MRU | Implanted Subcortical Electrical Stimulator (Motor Disorders) | Unknown | Class f | N/A | 2016-03-31 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2018-07-31 |
| OLM | Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) | Unknown | Class f | N/A | 2016-03-31 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2016-05-03 |
| LPB | Cardiac Ablation Percutaneous Catheter | Unknown | Class 3 | N/A | 2015-11-20 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2015-02-05 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | Class 2 | 882.5870 | 2015-02-05 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2012-11-29 |
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | Class 2 | 870.3680 | 2014-05-16 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2012-11-29 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | Class 2 | 882.5870 | 2015-02-05 |
| DTA | Tester, Pacemaker Electrode Function | Cardiovascular | Class 2 | 870.3720 | 2011-01-05 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Unknown | Class 3 | N/A | 2012-11-29 |
| MBX | Stimulator, Thalamic, Epilepsy, Implanted | Unknown | Class 3 | N/A | 2012-11-29 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Unknown | Class 3 | N/A | 2012-11-29 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014255018 | Ametek EMC | Reynosa Tamaulipas, MX |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K190960 | Boston Scientific Neuromodulation | Nalu Lead Blank (50cm) | 2019-07-11 |
| K150517 | Stimwave Technologies Incorporated | Freedom Spinal Cord Stimulator System | 2015-06-05 |
| K945103 | Medtronic Vascular | TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) | 1995-01-11 |
| K881966 | C.R. Bard, Inc. | ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER | 1988-10-04 |
| K192037 | ABBOTT MEDICAL | Advisor VL Circular Mapping Catheter, Sensor Enabled | 2019-09-17 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0002-2007 | Guidant Corporation | 3 | Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. |
| Z-0003-2018 | St Jude Medical Inc. | 3 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q
Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing |
| Z-0037-2012 | Boston Scientific CRM Corp | 3 | LATITUDE Paceart Integration Software, version 1.00 Model 6472.
LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493.
When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system. |
| Z-0016-2011 | Boston Scientific CRM Corp | 3 | Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798
CONTAK RENEWAL 4/4RF Models H190*, H195*, H197*, H199*, M170*, M175*, M177*, M179*, H230*, H235*, H239*
*Not available in the US |
| Z-0025-2014 | Boston Scientific CRM Corp | 3 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009380063 | Medtronic Distribution Center | Memphis, TN, US |
| 3005334138 | St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, US |
| 2124215 | Boston Scientific Corporation | Saint Paul, MN, US |
| 9614453 | Medtronic Europe Sarl | TOLOCHENAZ Vaud, CH |
| 1000121056 | Boston Scientific Corporation | Coventry, RI, US |
2135338 when referencing this establishment in official correspondence.