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
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.PJS2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.PJS2026-08-07
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2026-06-08
06974847962736JEDHebei Jiede Medical Equipment Co., Ltd.KMN2026-06-04
00199309002416N/AMEDTRONIC, INC.PJS2026-05-29
00199150021277NAMEDTRONIC, INC.LKK2026-05-02
00199150006045N/AMEDTRONIC, INC.PJS2026-02-02
06970006390105DAYANGGuangdong Dayang Medical Technology Co.,LtdKMN2025-11-20
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
00191506047733Vercise ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2024-06-14
00191506014339Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2023-10-02
00817463026634Oakworks MedicalOAKWORKS, INC.KMN2023-08-21
00191506023218Vercise ™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2023-07-18
00840117324756Dynarex Bari + Max Bariatric HD Overbed Table, CherryDynarex CorporationKMN2022-11-02
00191506023584NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPJS2022-10-31
00763000634094SYNCHROMED® IIMEDTRONIC, INC.LKK2022-08-11
00763000634100SYNCHROMED® IIMEDTRONIC, INC.LKK2022-08-11
00850014110079INTERAIntera Oncology Inc.LKK2021-08-13
00850014110147INTERAIntera Oncology Inc.LKK2021-07-28
00850014110154INTERAIntera Oncology Inc.LKK2021-07-28