FDA.reportPublic FDA data

N/A

Primary DI
00763000404413
Brand
N/A
Company
MEDTRONIC, INC.
Model
37022
Device description
ENS 37022 EXTERNAL STIM DBS EMANUAL EN
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGWStimulator, spinal-cord, totally implanted for pain relief
MBXStimulator, thalamic, epilepsy, implanted
MFRStimulator, brain, implanted, for behavior modification
MHYStimulator, electrical, implanted, for parkinsonian tremor
MRUimplanted subcortical electrical Stimulator (motor disorders)
NHLStimulator, electrical, implanted, for parkinsonian symptoms
OLMDeep brain stimulator for obsessive compulsive disorder (OCD)
PJSStimulator, electrical, implanted, for essential tremor
SGSDeep Brain Stimulation for the treatment of Dystonia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
MBXStimulator, Thalamic, Epilepsy, ImplantedUnknown3
MFRStimulator, Brain, Implanted, For Behavior ModificationUnknownf
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Unknownf
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)Unknownf
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3
SGSDeep Brain Stimulation For The Treatment Of DystoniaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020007301
H050003267
P960009408

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007301
H050003267
P960009408MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000404413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000404413007630004044137630004044130763000404413

GMDN Terms#

Term, Definition table
TermDefinition
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generatorAn electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09352307001930Evoke® RECAP® ViewerSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
09352307002111Evoke® Clarity® Programming ApplicationSALUDA MEDICAL PTY LIMITEDLGW2026-07-06
00191506070564NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.SGS2026-05-29
00199309002416N/AMEDTRONIC, INC.OLM2026-05-29
00199309002416N/AMEDTRONIC, INC.MBX2026-05-29
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
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08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
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08714729966401NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15