FDA.reportPublic FDA data

InterStim™

Primary DI
20763000343327
Brand
InterStim™
Company
MEDTRONIC, INC.
Model
367675
Device description
CABLE 367675 ISTM UNIPLR PAT 3W GLBL MDR
Published
2021-01-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZWStimulator, electrical, implantable, for incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080025113
P970004218

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025113MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON
P970004218MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000343327PrimaryGS10
00763000343323Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300034332720763000343327
00763000343323007630003433237630003433230763000343323

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
6
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850075633135Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633425Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633432Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633449Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633456Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633463Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633470Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00850075633487Neuspera SNM SystemNeuSpera Medical Inc.EZW2026-04-29
00199150005918NAMEDTRONIC, INC.EZW2026-03-27
00199150005925NAMEDTRONIC, INC.EZW2026-03-27
00850075633081Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-12-02
00850075633012Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633029Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633036Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633043Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633067Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633098Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633104Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633111Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633128Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633142Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633159Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633166Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633173Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633180Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633197Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633203Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633210Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633227Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17
00850075633234Neuspera SNM SystemNeuSpera Medical Inc.EZW2025-11-17