Device |
stimulator, spinal-cord, implanted, for bladder evacuation |
Regulation Description |
Implanted spinal cord stimulator for bladder evacuation. |
Definition |
Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96 |
Regulation Medical Specialty |
Neurology |
Review Panel |
Gastroenterology/Urology |
Product Code | GZD |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
Submission Type |
PMA
|
Regulation Number |
882.5850
|
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? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |
|
|