| Device |
transvenous temporary phrenic nerve stimulator |
| Definition |
The device is intended to be implanted transvenously to stimulate the phrenic nerves to improve weaning from a mechanical ventilator. The device is temporary (<30 days) and is for use only in patients 18 years of age or older. |
| Physical State |
The device consists of a neurostimulation catheter and a console to control the stimulation delivery. |
| Technical Method |
A neurostimulation catheter is inserted in the jugular vein or subclavian vein and passed through the superior vena cava, overlaying the left and right phrenic nerves. The system detects a breath, either through manual activation or connection to the breathing circuit, and transmits electrical stimulation to initiate diaphragmatic contractions. |
| Target Area |
Diaphragm, phrenic nerves. |
| Review Panel |
Anesthesiology |
|---|
| Product Code | SDL |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
