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InterStim™ SureScan™

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
InterStim™ SureScan™ FDA UDI
Generic Name
Sacral plexus implantable incontinence-control electrical stimulation system electrode FDA UDI
Device Name
LEAD 978B133 ISTM SSMRI 4.32MM EMAN US FDA UDI
Model / Reference
978B133 FDA UDI
Description
LEAD 978B133 ISTM SSMRI 4.32MM EMAN US FDA UDI

Identifiers

Primary DI / UDI-DI
00763000203764 FDA UDI
PMA Number
P080025 FDA UDI
P970004 FDA UDI
FDA Product Code
EZW FDA UDI
GMDN Term
Sacral plexus implantable incontinence-control electrical stimulation system electrode FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
876.5270 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 33.0 Centimeter FDA UDI

Category: Sacral plexus implantable incontinence-control electrical stimulation system electrode

InterStim™ SureScan™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacral plexus implantable incontinence-control electrical stimulation system electrode.

Cleared under the same submission

P080025 also covers:

P970004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI cea6088a-df56-4efc-860a-ccb0040f11f8 36 fields · synced Jun 8, 2026