PMA supplement
P140009 S046: Infinity family of DBS IPGs
FDA PMA supplement · Normal 180 Day Track · ABBOTT MEDICAL
Key facts
| Original PMA | P140009 |
|---|---|
| Supplement number | S046 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Infinity family of DBS IPGs |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | ABBOTT MEDICAL |
| Product code | MHY |
| Received date | Mar 21, 2019 |
| Decision date | Sep 17, 2019 |
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: