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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.
900-007-001
In Commercial Distribution
- 10855728005366 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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.
900-007-019
In Commercial Distribution
- 10810098650264 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
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.
900-007-017
In Commercial Distribution
- 10810098650141 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Battery
EBR Systems, Inc.
3100
In Commercial Distribution
- 00859244007029 ()
- Implantable pacemaker battery
Transmitter
EBR Systems, Inc.
4100
In Commercial Distribution
- 00859244007005 ()
- Left-ventricular wireless pacing system sensor/transmitter
XIENCE Alpine Everolimus Eluting Coronary Stent System 4.00 mm x 12 mm / Over-The-Wire
ABBOTT VASCULAR INC.
1145400-12
In Commercial Distribution
- 08717648200328 ()
1145400-12
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.25 mm x 28 mm / Over-The-Wire
ABBOTT VASCULAR INC.
1145325-28
In Commercial Distribution
- 08717648200182 ()
1145325-28
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.25 mm x 23 mm / Over-The-Wire
ABBOTT VASCULAR INC.
1145325-23
In Commercial Distribution
- 08717648200175 ()
1145325-23
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.25 mm x 18 mm / Over-The-Wire
ABBOTT VASCULAR INC.
1145325-18
In Commercial Distribution
- 08717648200168 ()
1145325-18
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.25 mm x 15 mm / Over-The-Wire
ABBOTT VASCULAR INC.
1145325-15
In Commercial Distribution
- 08717648200151 ()
1145325-15
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated