Device |
diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
Definition |
The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older. |
Physical State |
implanted electrodes, stimulator control, clinical programming station |
Technical Method |
provides electrical stimulation for diaphragm movement |
Target Area |
diaphragm |
Review Panel |
Anesthesiology |
Product Code | OIR |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
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 |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
Yes
|
Third Party Review |
Not Third Party Eligible |
|
|