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Global Neurostimulation Industry

8. NEUROSTIMULATION DEVICE APPROVALS II-29

SPR™ Therapeutics' SMARTPATCH™ Neurostimulation System

Obtains FDA's IDE Approval II-29

Bioness Receives FDA Clearance for Use of Smaller Leg Cuff

with L300 Foot Drop System II-29

Imthera Medical's AURA6000 Awarded CE Mark for Sleep Apnea

Therapy II-29

Neuronetics' Magnetic Brain Stimulation Device Receives CE

Approval II-30

St. Jude Medical's Eon Mini Stimulator Obtains European CE

Mark Approval II-30

Boston Scientific's Precision Plus SCS Wins FDA Approval for

Limb Pain II-30

Boston Scientific's Infinion™ 16 Percutaneous Lead Obtains CE

Approval II-30

NeuroSigma Obtains CE Approval for Monarch Nerve Stimulation

System II-31

Neurotech's ADNS-300 Neurostimulation Device Obtains CE Mark

Approval II-31

Bioness Bags FDA Approval for NESS L300 Plus, for Managing

Thigh Weakness II-31

Bioness Obtains CE Mark Approval and FDA Clearance For NESS

H200 Hand Rehabilitation System II-31

Boston Scientific's Clik Anchor Obtains FDA Approval II-32

Medtronic's AdaptiveStim RestoreSensor Lands US FDA Approval II-32

Synapse Biomedical Obtains FDA Approval for NeuRx Diaphragm

Pacing System II-32

St Jude Medical's Genesis System Secures CE Mark Approval II-32

St. Jude Receives Approval for Neurostimulation System from

Japanese MHLW II-33

St. Jude Secures European CE Mark Approval for Epiducer™ Lead

Delivery System II-33

St. Jude Medical Obtains TGA Approval for Brio™ DBS System II-33

Boston Scientific Secures FDA Approval for D4 and W4 SCS Lead

Splitters II-33

St. Jude Medical Receives Approval for Penta Neurostimulation

Lead from FDA II-34

St. Jude Receives European CE Mark Approval for LibraXP™ and

Libra® Deep Brain Stimulation Systems II-34

Medtronic Receives FDA Approval for Activa PC and Activa RC

DBS Devices II-34

Medtronic Receives FDA Approval for Reclaim™ Deep Brain

Stimulation Therapy II-34

St. Jude Receives European CE Mark Approval for Genesis®

Neurostimulation System II-35

St. Jude Eon Mini™ Neurostimulator Receives Australian

Therapeutic Goods Administration Approval II-35

Medtronic Receives FDA Approval for Activa® RC, Activa PC DBS

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