FDA.reportPublic FDA data

NA

Primary DI
00763000875718
Brand
NA
Company
MEDTRONIC, INC.
Model
8880T2-RFB
Device description
COMMUNICATOR 8880T2 CLN CTM REFRB US
Published
2023-11-16
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
LKKPump, infusion, implanted, programmable
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
LKKPump, Infusion, Implanted, ProgrammableUnknown3
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
H020007207
H050003176
P840001344
P860004281
P960009304

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007207
H050003176
P840001344ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P860004281MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMMedtronic, Inc.1988-03-14LKK
P960009304MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000875718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000875718007630008757187630008757180763000875718

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
796986144
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.MBX2026-05-29
00199309002416N/AMEDTRONIC, INC.OLM2026-05-29
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
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
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 CORPORATIONPJS2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15