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Inspire

FDA UDI

Class III (US FDA UDI)

by Inspire Medical Systems

Identity

Trade Name
Inspire FDA UDI
Generic Name
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI
Device Name
The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions. FDA UDI
Model / Reference
900-015-001 FDA UDI
Description
The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions. FDA UDI

Identifiers

Catalog Number
3150 FDA UDI
Primary DI / UDI-DI
10855728005960 FDA UDI
PMA Number
P130008 FDA UDI
FDA Product Code
MNQ FDA UDI
GMDN Term
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system FDA UDI

Classification

Device Class
Class III 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

Inspire by Inspire Medical Systems — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system.

Cleared under the same submission

P130008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inspire Medical Systems

Sources (1)

  • FDA UDI b8fe624f-ddb9-41bf-a1f9-1740a7eb47e9 35 fields · synced May 31, 2026