PMA supplement
P140009 S011: GENESIS,EON,EON C, EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES
FDA PMA supplement · 30-Day Notice · ABBOTT MEDICAL
Key facts
| Original PMA | P140009 |
|---|---|
| Supplement number | S011 |
| Supplement type | 30-Day Notice |
| Trade name | GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | ABBOTT MEDICAL |
| Product code | MHY |
| Received date | Jan 27, 2016 |
| Decision date | Feb 26, 2016 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: