ClearanceBrief
Product code MHY ยท Class 3

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

0510(k)s in 12 months (0 all time)
3recalls in 12 months (46 all time)
0recalls that name a 510(k)
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Top companies in MHY

DateFirm and productCodeLinked 510(k)
May 28, 2026Medtronic Neuromodulation
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
May 28, 2026Medtronic Neuromodulation
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Open, Classified
MHYNone listed
Nov 7, 2025Abbott Medical
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Open, Classified
MHYNone listed
Oct 23, 2024Medtronic Neuromodulation
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Open, Classified
MHYNone listed
Jul 25, 2024Abbott Medical
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Open, Classified
MHYNone listed
Jul 25, 2024Abbott Medical
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Open, Classified
MHYNone listed
Jul 25, 2024Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Open, Classified
MHYNone listed
Jul 25, 2024Abbott Medical
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Open, Classified
MHYNone listed
Jul 24, 2024Medtronic Neuromodulation
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
Open, Classified
MHYNone listed
Jul 3, 2024Abbott Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Open, Classified
MHYNone listed
Nov 3, 2023Medtronic Neuromodulation
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Completed
MHYNone listed
Oct 18, 2023Medtronic Neuromodulation
SenSight Connector Plug, Model Number B31061.
Open, Classified
MHYNone listed
Apr 19, 2023Medtronic Neuromodulation
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Open, Classified
MHYNone listed
Mar 30, 2022Medtronic Neuromodulation
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Open, Classified
MHYNone listed
Nov 4, 2021Medtronic Neuromodulation
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Open, Classified
MHYNone listed
Oct 19, 2021Medtronic Neuromodulation
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Open, Classified
MHYNone listed
Sep 23, 2021Medtronic Neuromodulation
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Open, Classified
MHYNone listed
Mar 9, 2021Medtronic Neuromodulation
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* *
Open, Classified
MHYNone listed
Nov 19, 2020Medtronic Neuromodulation
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease,
Terminated
MHYNone listed
Oct 11, 2018St. Jude Medical, Inc.
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Le
Terminated
MHYNone listed
Sep 12, 2017St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Terminated
MHYNone listed
Jun 2, 2017St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a
Terminated
MHYNone listed
Jun 2, 2017St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a
Terminated
MHYNone listed
Jun 2, 2017St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a
Terminated
MHYNone listed
Jun 2, 2017St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by
Terminated
MHYNone listed
Mar 17, 2017Medtronic Neuromodulation
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 accessorie
Terminated
MHYNone listed
Oct 3, 2016Medtronic Neuromodulation
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the
Terminated
MHYNone listed
Jun 23, 2016Medtronic Neuromodulation
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 po
Terminated
MHYNone listed
Jun 10, 2016Medtronic Neuromodulation
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Terminated
MHYNone listed
May 15, 2015Medtronic Neuromodulation
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Terminated
MHYNone listed
Aug 18, 2014Medtronic Neuromodulation
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulati
Terminated
MHYNone listed
Apr 29, 2014Medtronic Neuromodulation
Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders
Terminated
MHYNone listed
Nov 14, 2013Medtronic Neuromodulation
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
Terminated
MHYNone listed
May 1, 2013Medtronic Neuromodulation
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical sti
Terminated
MHYNone listed
Feb 28, 2013Advanced Neuromodulation Systems Inc.
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Terminated
MHYNone listed
Dec 19, 2012Medtronic Neuromodulation
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 Diseas
Terminated
MHYNone listed
Oct 27, 2008Medtronic Neuromodulation
Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tre
Terminated
MHYNone listed
Oct 27, 2008Medtronic Neuromodulation
Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tr
Terminated
MHYNone listed
Oct 27, 2008Medtronic Neuromodulation
Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Th
Terminated
MHYNone listed
Oct 27, 2008Medtronic Neuromodulation
Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length: 40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Th
Terminated
MHYNone listed
Feb 5, 2008Medtronic Neuromodulation
Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantab
Terminated
MHYNone listed
Feb 5, 2008Medtronic Neuromodulation
Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a mult
Terminated
MHYNone listed
Jun 15, 2007Medtronic Neuromodulation
Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
Terminated
MHYNone listed
Dec 19, 2006Medtronic Neurological
Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428
Terminated
MHYNone listed
May 27, 2006Medtronic Neurological
Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Kinetra neurostimulator is a com
Terminated
MHYNone listed
Jan 10, 2006Medtronic Inc, Neurological & Spinal Division
Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model
Terminated
MHYNone listed

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