FDA.reportPublic FDA data

NA

Primary DI
00613994353337
Brand
NA
Company
MEDTRONIC, INC.
Model
7438
Device description
PRGM 7438 SOLETRA EZ PATIENT US MKT
Published
2014-09-23
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
MFRStimulator, brain, implanted, for behavior modification
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
MFRStimulator, Brain, Implanted, For Behavior ModificationUnknownf
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
H020007000
H050003000
P960009019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H020007000
H050003000
P960009019MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994353337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994353337006139943533376139943533370613994353337

GMDN Terms#

Term, Definition table
TermDefinition
Active-implantable-device communicatorA non-sterile electronic device, typically hand-held, intended to be used to communicate (e.g., via radio-frequency) with an active implantable device (e.g., a pulse generator) to receive information on device and/or physiologic performance, and/or to select and actuate one or more of the programmed operating parameters of the implanted device. This device may be operated by a physician or patient.

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
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
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNHL2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
00199309002416N/AMEDTRONIC, INC.OLM2026-05-29
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199309002416N/AMEDTRONIC, INC.NHL2026-05-29
00199150017850N/AMEDTRONIC, INC.MRU2026-02-05
00199150017850N/AMEDTRONIC, INC.NHL2026-02-05
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00199150006045N/AMEDTRONIC, INC.OLM2026-02-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
00199150006045N/AMEDTRONIC, INC.MRU2026-02-02
00199150006045N/AMEDTRONIC, INC.NHL2026-02-02
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 CORPORATIONPJS2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
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