FDA.reportPublic FDA data

InterStim™

Primary DI
20763000114064
Brand
InterStim™
Company
MEDTRONIC, INC.
Model
041839
Device description
NEEDLE 041839 FORAMN 5IN 18.5GA GLBL 2PK
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZWStimulator, electrical, implantable, for incontinence
QONImplanted electrical device intended for treatment of fecal incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3
QONImplanted Electrical Device Intended For Treatment Of Fecal IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080025187
P970004292

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025187MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON
P970004292MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000114064PrimaryGS10
00763000114060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300011406420763000114064
00763000114060007630001140607630001140600763000114060

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.6Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
2
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005918NAMEDTRONIC, INC.QON2026-03-27
00199150005925NAMEDTRONIC, INC.QON2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
10810005340523AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2025-02-05
10810005340578AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2024-07-29
00763000596835InterStim™SureScan™MEDTRONIC, INC.QON2024-01-22
00763000596873InterStim™SureScan™MEDTRONIC, INC.EZW2024-01-22
00763000612832N/AMEDTRONIC, INC.EZW2024-01-19
00763000612832N/AMEDTRONIC, INC.QON2024-01-19
00763000596798InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
00763000596910InterStim™SureScan™MEDTRONIC, INC.QON2023-12-15
10810005340479AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2023-09-08
00763000825997NAMEDTRONIC, INC.EZW2023-04-07
00763000826000NAMEDTRONIC, INC.EZW2023-04-07
00763000596996InterStim™SureScan™MEDTRONIC, INC.QON2023-01-23
00763000596958InterStim™SureScan™MEDTRONIC, INC.EZW2023-01-01
10810005340486AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-06-14
00763000596736InterStim™ Micro SureScan™ MRIMEDTRONIC, INC.EZW2022-06-05
10810005340455AxonicsAXONICS MODULATION TECHNOLOGIES, INC.QON2022-03-11
00763000484668InterStim™ XMEDTRONIC, INC.EZW2022-03-04
00763000517182NAMEDTRONIC, INC.QON2022-03-04
00763000517199NAMEDTRONIC, INC.QON2022-03-04
00763000582470NAMEDTRONIC, INC.QON2022-03-04
00763000582487NAMEDTRONIC, INC.EZW2022-03-04
00763000449711INTERSTIM® IIMEDTRONIC, INC.EZW2021-05-30
00763000433864N/AMEDTRONIC, INC.QON2021-05-21
00763000433871N/AMEDTRONIC, INC.QON2021-05-21
00763000343286NAMEDTRONIC, INC.QON2021-02-15
00763000295523InterStim™MEDTRONIC, INC.QON2021-01-25