FDA.reportPublic FDA data

N/A

Primary DI
00763000424107
Brand
N/A
Company
MEDTRONIC, INC.
Model
TH90D01
Device description
COMM HANDSET KIT TH90D01 DBS A10E PPR EN
Published
2021-04-18
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
MBXSTIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBXStimulator, Thalamic, Epilepsy, ImplantedUnknown3
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020007257
H050003226
P960009361

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007257
H050003226
P960009361MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000424107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000424107007630004241077630004241070763000424107

GMDN Terms#

Term, Definition table
TermDefinition
Multiple active implantable device programmerAn external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-35 Degrees Celsius58 Degrees Celsius
Storage Environment Temperature-31 Degrees Fahrenheit136 Degrees Fahrenheit

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
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.OLM2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MBX2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MBX2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
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
B1132L1S0400020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1000020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1000030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1200020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.MBX2025-12-12
B1132L1S1200030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.MBX2025-12-12
B1132L2HB000020Shoulder Innovations InSet 135 Instrument Case/TrayShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB000030Shoulder Innovations InSet 185 Instrument Case/TrayShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235040Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12
B1132L2HB235060Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.MBX2025-12-12