Device |
stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy |
Definition |
To relieve pain in patients with diabetic neuropathy |
Physical State |
Pulse generator, leads, accessories, software |
Technical Method |
An implantable pulse generator provides electrical stimulation to the spinal cord using implanted leads, resulting in pain relief |
Target Area |
Spinal cord |
Review Panel |
Neurology |
Product Code | QRB |
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 |
|
|