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InterStim iCon

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
InterStim iCon FDA UDI
Generic Name
Implantable incontinence-control electrical stimulation system programmer, battery-powered FDA UDI
Device Name
PRGMR 3037 INTERSTIM PATIENT SW UPDATE FDA UDI
Model / Reference
3037 FDA UDI
Description
PRGMR 3037 INTERSTIM PATIENT SW UPDATE FDA UDI

Identifiers

Primary DI / UDI-DI
00613994572059 FDA UDI
PMA Number
P970004 FDA UDI
FDA Product Code
EZW FDA UDI
QON FDA UDI
GMDN Term
Implantable incontinence-control electrical stimulation system programmer, battery-powered 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Implantable incontinence-control electrical stimulation system programmer, battery-powered

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

Similar devices

Also classified as Implantable incontinence-control electrical stimulation system programmer, battery-powered.

Cleared under the same submission

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 161023d4-997e-4da7-b111-9b8891ae0701 36 fields · synced Jun 1, 2026