FDA.reportPublic FDA data

N/A

Primary DI
00763000292102
Brand
N/A
Company
MEDTRONIC, INC.
Model
TM90D0
Device description
COMMUNICATOR TM90D0 DBS US PAPER EN
Published
2025-09-05
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
MRUimplanted subcortical electrical Stimulator (motor disorders)
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)Unknownf
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000292102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000292102007630002921027630002921020763000292102

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
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00199150017850N/AMEDTRONIC, INC.MRU2026-02-05
00199150006045N/AMEDTRONIC, INC.MRU2026-02-02
00763000994198N/AMEDTRONIC, INC.MRU2025-10-19
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00841492101574ResponderRAULAND-BORG CORPORATIONOUG2025-06-20
00763000975029N/AMEDTRONIC, INC.MRU2025-03-07
68051887046715THD Procto Software SystemTHD SPAOUG2025-02-20
00763000963040N/AMEDTRONIC, INC.MRU2025-02-17
00763000963057N/AMEDTRONIC, INC.MRU2025-02-17
00763000574598NAMEDTRONIC, INC.OUG2025-02-10
00643169955653N'VISION®MEDTRONIC, INC.MRU2024-10-04
00763000924621Activa® SCMEDTRONIC, INC.MRU2024-05-30
00763000924614Activa® SCMEDTRONIC, INC.MRU2024-05-27
00763000916268Percept™ PC BrainSense™MEDTRONIC, INC.MRU2024-04-21
00763000662028N/AMEDTRONIC, INC.MRU2024-03-03
00763000564353N/AMEDTRONIC, INC.MRU2024-01-22
00763000650544N/AMEDTRONIC, INC.OUG2024-01-22
00763000650551N/AMEDTRONIC, INC.OUG2024-01-22
00763000564346Percept™ RCMEDTRONIC, INC.MRU2024-01-21
00763000523312N/AMEDTRONIC, INC.MRU2024-01-19
00763000612832N/AMEDTRONIC, INC.MRU2024-01-19
68051887043295THD Procto Software SystemTHD SPAOUG2023-12-14
68051887043301THD Procto Software SystemTHD SPAOUG2023-12-14
68051887043318THD Procto Software SystemTHD SPAOUG2023-12-14
68051887043325THD Procto Software SystemTHD SPAOUG2023-12-14