FDA.reportPublic FDA data

Inspire

Primary DI
00855728005192
Brand
Inspire
Company
Inspire Medical Systems, Inc.
Model
900-002-007
Catalog number
4323
Device description
The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration
Published
2017-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P130008001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130008001INSPIRE II UPPER AIRWAY STIMULATORInspire Medical Systems2014-04-30MNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855728005192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855728005192008557280051928557280051920855728005192

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
10855728005960Inspire900-015-00131502024-12-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404031018723Genio System 2.1NyxoahMNQ2025-08-27
05404031000001Genio System 2.1NyxoahMNQ2025-08-26
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
10855728005960InspireInspire Medical Systems, Inc.MNQ2024-12-06
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