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Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
1501
In Commercial Distribution
- 10810005340028 ()
1501
- Implantable incontinence-control electrical stimulation system programmer, line-powered
No Description
DEFIBTECH, L.L.C.
DDU-E2200
In Commercial Distribution
- 10815098020192 ()
- Non-rechargeable public automated external defibrillator
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-005
In Commercial Distribution
- 10810098650301 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution
- 10810098650295 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
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
The Coaptite Injectable implant is a permanently implanted device to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles
MERZ NORTH AMERICA, INC.
8005M0
In Commercial Distribution
- 10810235030645 ()
- Dermal tissue reconstructive material, synthetic mineral
Dermal HA filler for NLF - Sample
SYMATESE
EVOF1F001-S
In Commercial Distribution
- 03760172161288 ()
EVO-FRM-01-S
- Dermal tissue reconstructive material, microbe-derived, anaesthetic
Anti-HBe Elecsys E2G 300
Roche Diagnostics GmbH
07026838190
In Commercial Distribution
- 04015630940134 ()
07026838190
- Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution
- 04015630939862 ()
07027427190
- Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay