HDE supplement
H980008 S001: NEUROCONTROL VOCARE BLADDER SYSTEM
FDA HDE supplement · normal 75 day track · MDCI MEDICAL DEVICE CONSULTANTS, INC.
Key facts
| Original HDE | H980008 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | NEUROCONTROL VOCARE BLADDER SYSTEM |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | MDCI MEDICAL DEVICE CONSULTANTS, INC. |
| Product code | EZW |
| Received date | Jan 7, 2000 |
| Decision date | Jan 10, 2000 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: