DEVICE: Inspire (10855728005960)
Device Identifier (DI) Information
Inspire
900-015-001
In Commercial Distribution
3150
Inspire Medical Systems, Inc.
900-015-001
In Commercial Distribution
3150
Inspire Medical Systems, Inc.
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.
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34210 | Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system |
An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P130008 | 098 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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Device Record Status
b8fe624f-ddb9-41bf-a1f9-1740a7eb47e9
December 16, 2024
1
December 06, 2024
December 16, 2024
1
December 06, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined