FDA.reportPublic FDA data

NA

Primary DI
00613994997937
Brand
NA
Company
MEDTRONIC, INC.
Model
8529
Device description
MAGNET 8529 PHYS PROGRMR 8840 US 60601
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
KMNCHAIR AND TABLE, MEDICAL
LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE
PJSStimulator, electrical, implanted, for essential tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMNChair And Table, MedicalGeneral Hospital1
LKKPump, Infusion, Implanted, ProgrammableUnknown3
PJSStimulator, Electrical, Implanted, For Essential TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860004052

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860004052MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMMedtronic, Inc.1988-03-14LKK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994997937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994997937006139949979376139949979370613994997937

GMDN Terms#

Term, Definition table
TermDefinition
Implantable stimulator control magnetA hand-operated, non-sterile, magnetic device designed to be used by a patient to switch an implanted stimulator (e.g., a neurostimulator that can be controlled by a strong external magnetic force) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implanted stimulator and turned as prescribed by the manufacturer to affect the stimulator. This is a reusable device.

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
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
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199150021277NAMEDTRONIC, INC.LKK2026-05-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
B845CBZ0411WOTUREIntco Medical Industries, Inc.KMN2025-03-28
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2025-02-24
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966364Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729966401NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
08714729989240Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-12-15
00643169955653N'VISION®MEDTRONIC, INC.PJS2024-10-04
00191506047733Vercise ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-06-14
00191506014339Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2023-10-02
00191506023218Vercise ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2023-07-18
00191506023584NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2022-10-31
08714729985037Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-06-25
08714729985051Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-06-25
08714729966418NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729985020Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729989196Vercise™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729989202Vercise™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729989271NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729992141Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
08714729996729NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2021-01-28
B510CHT10000ADVANCED TROLLEYADVANCED INSTRUMENTATIONS, INC.KMN2020-05-27
B510CHT20000ADVANCED TROLLEYADVANCED INSTRUMENTATIONS, INC.KMN2020-05-27