FDA.reportPublic FDA data

Infinity™

Primary DI
05415067055866
Brand
Infinity™
Company
ADVANCED NEUROMODULATION SYSTEMS, INC.
Model
6884
Catalog number
6884
Device description
Patient Manual and Magnet
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHYStimulator, electrical, implanted, for parkinsonian tremor
NHLStimulator, electrical, implanted, for parkinsonian symptoms
PJSStimulator, electrical, implanted, for essential tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3
NHLStimulator, Electrical, Implanted, For Parkinsonian SymptomsUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140009124

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140009124BRIO NEUROSTIMULATION SYSTEMABBOTT MEDICAL2015-06-12MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067023988PreviousGS10
05415067055866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067023988054150670239885415067023988
05415067055866054150670558665415067055866

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
021675699
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054111N/A121012102026-03-02
05415067055880Proclaim™788478842026-02-13
05415067055842Proclaim™388438842026-02-13
05415067053060NAMN13650MN136502025-12-07
05415067051899NA66700667002025-01-24
05415067051905NA36700367002025-01-24
05415067047670NA66000660002024-02-16
05415067045652NA16750167502023-01-04
05415067045676NA16760167602023-01-04
05414734400107NA111211122014-11-12
05414734400176NA112011202014-10-23
05415067023971Proclaim™388438842016-03-31
05415067051882NA304230422025-04-09
05415067050311NeuroSphere™387638762025-01-17
05415067045713NA12710127102023-01-04
05414734401500NA300930092015-04-25
05414734400961MTS™127312732014-10-22
05414734401548Quattrode™306630662015-04-25
05415067027313Proclaim™788478842017-03-23
05415067029072NA788578852017-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.NHL2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.NHL2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00199150017850N/AMEDTRONIC, INC.NHL2026-02-05
00199150006045N/AMEDTRONIC, INC.NHL2026-02-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2024-12-15
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
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 CORPORATIONNHL2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15