Device |
stimulator, intracerebral/subcortical, implanted |
Regulation Description |
Implanted intracerebral/subcortical stimulator for pain relief. |
Definition |
Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88 |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | GYZ |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
PMA
|
Regulation Number |
882.5840
|
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
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |