Inspire

Primary DI
10855728005960
Brand
Inspire
Company
Inspire Medical Systems, Inc.
Model
900-015-001
Catalog number
3150
Device 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.
Published
2024-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNQStimulator, Hypoglossal Nerve, Implanted, ApneaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130008098

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130008098INSPIRE II UPPER AIRWAY STIMULATORInspire Medical Systems2014-04-30MNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855728005960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085572800596010855728005960

GMDN Terms#

Term, Definition table
TermDefinition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012419779
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810098650066Inspire900-023-00150302025-10-29
10855728005793Inspire900-013-00140632025-07-29
10810098650295Inspire900-013-00340632025-02-24
00855728005796Inspire900-013-00140632022-08-16
10810098650301Inspire900-014-00543402025-02-24
00810098650311Inspire900-026-0012740S&C2025-01-21
00810098650175Inspire900-017-00525802024-10-10
00810098650199Inspire900-017-05325802024-10-10
00855728005994Inspire900-018-0012740C2024-09-11
10810098650264Inspire900-007-01930282024-07-08
00810098650038Inspire900-029-0012740S2024-05-15
00810098650212Inspire900-004-11727402024-01-03
00810098650151Inspire900-004-11627402023-04-26
10810098650141Inspire900-007-01730282023-04-06
00810098650014Inspire900-017-005125802023-01-13
00810098650083Inspire900-017-00325802022-09-29
00855728005949Inspire900-014-00343402022-08-16
00855728005925Inspire900-017-00125802022-05-09
00810098650007Inspire900-004-11527402022-01-26
00855728005741Inspire900-004-11127402021-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05404031000018Genio System 2.1NyxoahMNQ2025-08-26
05404031000025Genio System 2.1NyxoahMNQ2025-08-26
05404031000049Genio System 2.1NyxoahMNQ2025-08-26
05404031018693Genio System 2.1NyxoahMNQ2025-08-26
05404031024755Genio System 2.1NyxoahMNQ2025-08-26
05404031024786Genio System 2.1NyxoahMNQ2025-08-26
05404031024823Genio System 2.1NyxoahMNQ2025-08-26
05404031024847Genio System 2.1NyxoahMNQ2025-08-26
05404031025301Genio System 2.1NyxoahMNQ2025-08-26
10855728005793InspireInspire Medical Systems, Inc.MNQ2025-07-29
10810098650295InspireInspire Medical Systems, Inc.MNQ2025-02-24
10810098650301InspireInspire Medical Systems, Inc.MNQ2025-02-24
00810098650311InspireInspire Medical Systems, Inc.MNQ2025-01-21
00810098650175InspireInspire Medical Systems, Inc.MNQ2024-10-10
00810098650199InspireInspire Medical Systems, Inc.MNQ2024-10-10
00855728005994InspireInspire Medical Systems, Inc.MNQ2024-09-11
10810098650264InspireInspire Medical Systems, Inc.MNQ2024-07-08
00810098650038InspireInspire Medical Systems, Inc.MNQ2024-05-15
00810098650212InspireInspire Medical Systems, Inc.MNQ2024-01-03
00810098650151InspireInspire Medical Systems, Inc.MNQ2023-04-26
10810098650141InspireInspire Medical Systems, Inc.MNQ2023-04-06
00810098650014InspireInspire Medical Systems, Inc.MNQ2023-01-13
00810098650083InspireInspire Medical Systems, Inc.MNQ2022-09-29
00855728005796InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005949InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005925InspireInspire Medical Systems, Inc.MNQ2022-05-09
00810098650007InspireInspire Medical Systems, Inc.MNQ2022-01-26
00855728005741InspireInspire Medical Systems, Inc.MNQ2021-03-19