Device |
stimulator, autonomic nerve, implanted for stroke rehabilitation |
Definition |
Stimulation of the vagus nerve |
Physical State |
Implantable pulse generator, implantable lead, wireless transmitter |
Technical Method |
Uses implantable pulse generator and lead to stimulate vagus nerve |
Target Area |
Vagus nerve |
Review Panel |
Physical Medicine |
Product Code | QPY |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|