PMA supplement
P140009 S039: St. Jude Medical Infinity DBS Implantable Pulse Generator
FDA PMA supplement · Panel Track · ABBOTT MEDICAL
Key facts
| Original PMA | P140009 |
|---|---|
| Supplement number | S039 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | St. Jude Medical Infinity DBS Implantable Pulse Generator |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | ABBOTT MEDICAL |
| Product code | MHY |
| Received date | Jul 11, 2018 |
| Decision date | Jan 2, 2020 |
| Docket number | 20M-0097 |
| Notice date | Jan 7, 2020 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: