PMA supplement
P150031 S064: Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P150031 |
|---|---|
| Supplement number | S064 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System |
| Generic name | Stimulator, electrical, implanted, for parkinsonian symptoms |
| Applicant | Boston Scientific Corp |
| Product code | NHL |
| Received date | Sep 29, 2023 |
| Decision date | Feb 29, 2024 |
| Docket number | 24M-1051 |
| Notice date | Mar 1, 2024 |
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: