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The VisionAir 3D Stent (Patient-Specific Silicone Airway Stent) is comprised of a cloud-based software suite and the patient-specific airway stent. These two function together as a system to treat symptomatic stenosis of the airway per the indications for use. The implantable patient-specific airway stent is designed by a physician using a CT scan as a guide in the cloud-based software suite. The airway is segmented from the CT scan and used by the physician in designing a patient-specific stent. When design is complete, the stent is manufactured via silicone injection into a 3D-printed mold and delivered to the treating physician non-sterile, to be sterilized before use.
VisionAir Solutions, LLC
1
0010-0126
- Polymeric tracheal/bronchial stent, non-bioabsorbable
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Canary Medical USA LLC
43-5570-058-14
In Commercial Distribution
- 00860003118306 ()
- Knee femur stem prosthesis
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-117
In Commercial Distribution
- 00810098650212 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-116
In Commercial Distribution
- 00810098650151 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-115
In Commercial Distribution
- 00810098650007 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-071
In Commercial Distribution
- 10855728005410 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-102
In Commercial Distribution
- 00855728005826 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-111
In Commercial Distribution
- 00855728005741 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-101
In Commercial Distribution
- 00855728005642 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-073
In Commercial Distribution
- 00855728005550 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system