Inspire 3028

GUDID 10855728005366

The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

INSPIRE MEDICAL SYSTEMS INC

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

• Primary Device ID: 10855728005366
• NIH Device Record Key: 9bf23efd-9bab-4bef-8057-fac671cd98a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inspire
• Version Model Number: 900-007-001
• Catalog Number: 3028
• Company DUNS: 012419779
• Company Name: INSPIRE MEDICAL SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855728005366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130008

FDA Product Code

• MNQ: Stimulator, Hypoglossal Nerve, Implanted, Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-06-16

On-Brand Devices [Inspire]

• 10855728005632: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 00855728005437: The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titani
• 00855728005413: The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
• 00855728005338: The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
• 00855728005307: The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
• 00855728005277: The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
• 00855728005253: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00855728005222: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00855728005192: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 00855728005185: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 00855728005109: The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
• 00855728005093: The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
• 00855728005055: The Model 2740 physician programmer is designed for use by a physician to non-invasively interro
• 00855728005031: The patient programmer is an external device that is about the size of a cell phone or PDA, and
• 00855728005024: The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titani
• 00855728005017: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 00855728005000: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005533: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 10855728005656: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 00855728005642: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 00855728005611: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00855728005598: The sleep remote is an external device that is about the size of a cell phone and is used by the
• 00855728005550: The Model 2740 physician programmer is designed for use by a physician to non invasively interro
• 10855728005465: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 10855728005410: The Model 2740 physician programmer is designed for use by a physician to non‐invasively inter
• 10855728005403: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005397: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 10855728005366: The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. T
• 10855728005199: The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. T
• 10855728005182: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip
• 10855728005670: The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bip