HDE supplement
H020007 S002: MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM
FDA HDE supplement · normal 75 day track · MEDTRONIC NEUROMODULATION
Key facts
| Original HDE | H020007 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM |
| Applicant | MEDTRONIC NEUROMODULATION |
| Received date | Nov 4, 2003 |
| Decision date | Dec 11, 2003 |
| Docket number | 03M-0157 |
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: