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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·August 31, 2016

    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·August 30, 2017

    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ¿ Kinetra¿ Model 7428 or Soletra¿ Model 7426 Neurostimulator ¿ Activa¿ PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ¿ Soletra Model 7426 Neurostimulator ¿ Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ¿ Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ¿ Model 3387 or Model 3389 Lead.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·December 26, 2012

    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.

    FDA Enforcement
    Class II ·Terminated·Medtronic Cardiovascular Surgery-the Heart Valve Division·August 24, 2016

    LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

    FDA Enforcement
    Class II ·Completed·Medtronic Neuromodulation·November 8, 2023

    Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Neuromodulation Corporation·June 5, 2024

    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·August 31, 2016

    Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·June 24, 2026

    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neuromodulation·August 18, 2021

    Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019