FDA.reportPublic FDA data

N/A

Primary DI
00199150002191
Brand
N/A
Company
MEDTRONIC, INC.
Model
TM90D0
Device description
COMMUNICATOR TM90D0 DBS US EMAN NO CABLE
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150002191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150002191001991500021911991500021910199150002191

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.

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™W4TR012017-10-20
00643169891425Serena™ CRT-P MRI SureScan™W1TR022017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™W4TR022017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2025-11-17
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24