PMA
P960009: MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA PMA · Stimulator, electrical, implanted, for parkinsonian tremor · Medtronic, Inc.
Key facts
| PMA number | P960009 |
|---|---|
| Trade name | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM |
| Generic name | Stimulator, electrical, implanted, for parkinsonian tremor |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | MHY |
| Approval date | Jul 31, 1997 |
| Docket number | 98M-0905 |
| Notice date | Nov 12, 1998 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Oct 6, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: