FDA.reportPublic FDA data

INTERSTIM®

Primary DI
00643169651128
Brand
INTERSTIM®
Company
MEDTRONIC, INC.
Model
3889-33
Device description
LEAD 3889-33 ISTIM EMANUAL NO SCREENCBL
Published
2015-12-22
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080025000
P970004022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025000MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON
P970004022MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169651128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169651128006431696511286431696511280643169651128

GMDN Terms#

Term, Definition table
TermDefinition
Implantable incontinence-control electrical stimulation system electrodeAn implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence. It is implanted in the anal sphincter, bladder wall, sacral plexus and/or the pelvic floor to make an electrical connection between the intended site of electrical stimulation and the system pulse generator.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length33Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796986144
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00199150084067MiniMed Extended Supply KitMMT-445C2026-07-19
00824846004721NABB12S95R52026-07-19
00824846004738NABB12S26R2026-07-19
00824846004028NABB5722R492026-07-16
00824846003151NABB9F19R82026-07-09
00763000520083N/AA712002021-07-23
00643169711761Micra™MC1VR01US2018-01-13
00824846003472NABB10L84R92026-07-04

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