PMA supplement
P140009 S099: Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1
FDA PMA supplement · Real-Time Process · ABBOTT MEDICAL
Key facts
| Original PMA | P140009 |
|---|---|
| Supplement number | S099 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1 |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | ABBOTT MEDICAL |
| Product code | MHY |
| Received date | Jun 13, 2024 |
| Decision date | Aug 2, 2024 |
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: