Device |
stimulator, neuromuscular, implanted |
Regulation Description |
Implanted neuromuscular stimulator. |
Definition |
Call for PMAs to be filed by 7/13/99 per 64 FR 18329 on 4/14/99 |
Regulation Medical Specialty |
Neurology |
Review Panel |
Physical Medicine |
Product Code | GZC |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Rehabilitation Devices
(DHT5B)
|
Submission Type |
PMA
|
Regulation Number |
882.5860
|
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 |