PMA
P150031: VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
FDA PMA · Stimulator, electrical, implanted, for parkinsonian symptoms · Boston Scientific Corp
Key facts
| PMA number | P150031 |
|---|---|
| Trade name | VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM |
| Generic name | Stimulator, electrical, implanted, for parkinsonian symptoms |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NHL |
| Approval date | Dec 8, 2017 |
| Docket number | 17M-6800 |
| Notice date | Dec 15, 2017 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Sep 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: