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    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·April 6, 2016

    InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·June 19, 2019

    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:

    FDA Enforcement
    Class I ·Terminated·Medtronic Neuromodulation·July 3, 2013

    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids:

    FDA Enforcement
    Class I ·Terminated·Medtronic Neuromodulation·July 3, 2013

    Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·June 3, 2026

    Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·June 3, 2026

    Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·May 20, 2026

    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 21, 2026

    Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·December 31, 2025

    Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·April 16, 2025

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 8, 2025

    A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·April 9, 2025

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 8, 2025

    Vanta Implantable Neurostimulator (INS), Model 977006

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·October 23, 2024

    SynchroMed II Infusion Pump. Product Number: 8637-20

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·October 30, 2024

    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·January 8, 2025

    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·September 18, 2024

    Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·October 30, 2024

    A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·July 31, 2024

    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·May 8, 2024