FDA.reportPublic FDA data

N/A

Primary DI
00763000420994
Brand
N/A
Company
MEDTRONIC, INC.
Model
8880T2
Device description
COMMUNICATOR 8880T2 TELEM MOD EMAN US EN
Published
2020-12-21
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
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
QRBStimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
SGSDeep Brain Stimulation for the treatment of Dystonia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3
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
QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyUnknown3
SGSDeep Brain Stimulation For The Treatment Of DystoniaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H020007242
H050003211
P840001426
P860004328
P960009344

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007242
H050003211
P840001426ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSMedtronic Neuromodulation1984-11-30LGW
P860004328MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMMedtronic, Inc.1988-03-14LKK
P960009344MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000420994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000420994007630004209947630004209940763000420994

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00199309002416N/AMEDTRONIC, INC.SGS2026-05-29
04035479170295Tunneler LBIOTRONIK SE & Co. KGLGW2026-05-28
08714729837145Infinion™ 16BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONLGW2018-02-07
08714729820826Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820833Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820765NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820772NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820789NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820796Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820802SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820819SureTek™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820857Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820864Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15
08714729820871Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820949NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2017-12-15
08714729820949NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2017-12-15