FDA.reportPublic FDA data

InterStim™ SureScan™

Primary DI
00763000203603
Brand
InterStim™ SureScan™
Company
MEDTRONIC, INC.
Model
978A128
Device description
LEAD 978A128 ISTM SSMRI 2.16MM EMAN US
Published
2020-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
P080025197
P970004302

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080025197MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMMedtronic Neuromodulation2011-03-14QON
P970004302MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLMedtronic Neuromodulation1997-09-29EZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000203603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000203603007630002036037630002036030763000203603

GMDN Terms#

Term, Definition table
TermDefinition
Sacral plexus 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 on the sacral plexus or in its vicinity (e.g., anal sphincter, bladder wall, pelvic floor) to make an electrical connection between an implantable electrical stimulation system pulse generator and the sacral plexus area.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Centimeter

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
Kit
true
Lot or batch
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
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.QON2024-01-19
00763000612832N/AMEDTRONIC, INC.EZW2024-01-19
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
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
00763000295547InterStim™MEDTRONIC, INC.QON2021-01-25