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The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems.
The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-EX121245-J
In Commercial Distribution
- 00850007370022 ()
- Stent Diameter: 12 Millimeter
- Catheter Working Length: 60 Centimeter
- Outer Diameter: 12 Femtometer
- Lumen/Inner Diameter: 10 Femtometer
- Stent Length: 45 Millimeter
TV-EX121245-J
- Abdominal aorta endovascular stent-graft
"The Ovation iX™ Iliac Extensions are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems.
The Ovation iX™ Iliac Extensions are comprised of a nitinol stent encapsulated in low-permeability PTFE. Iliac extensions may be used to extend the length of the device, where indicated."
Endologix, Inc.
TV-EX101045-J
In Commercial Distribution
- 00850007370015 ()
- Stent Diameter: 10 Millimeter
- Catheter Working Length: 60 Centimeter
- Outer Diameter: 12 Femtometer
- Lumen/Inner Diameter: 10 Femtometer
- Stent Length: 45 Millimeter
TV-EX101045-J
- Abdominal aorta endovascular stent-graft
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data
and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution
- 00850008997051 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System.
The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include:
• Interrogates the Cordella Sensor to verify proper working condition.
• Facilitates linking of component serial numbers to patient IDs.
• Calibrates the Cordella Sensor to a reference pressure at the time of implantation.
• Trains patient on optimal Reader placement post-procedure.
• Recalibrates the Cordella Sensor to a reference pressure post-implant.
• CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution
- 00850008997020 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System.
The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution
- 00850008997013 ()
- Implantable pulmonary artery pressure monitoring system
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.
Cordella PA Sensor
The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.
Delivery System
The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution
- 00850008997006 ()
- Implantable pulmonary artery pressure monitoring system
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution
- 00850014110147 ()
- Total Volume: 30 Milliliter
AP03000H
- Implantable intrathecal infusion pump, nonprogrammable
LEAD 429888 ATTAIN PERFORMA USA
MEDTRONIC, INC.
429888
Not in Commercial Distribution
- 00643169002715 ()
- Length: 88.0 Centimeter
- Coronary venous pacing lead
LEAD 429878 ATTAIN PERFORMA USA
MEDTRONIC, INC.
429878
Not in Commercial Distribution
- 00643169002685 ()
- Length: 78.0 Centimeter
- Coronary venous pacing lead
LEAD 439878 ATTAIN PERFORMA USA
MEDTRONIC, INC.
439878
Not in Commercial Distribution
- 00643169002487 ()
- Length: 78.0 Centimeter
- Coronary venous pacing lead