PMA
P950035: NEUROCONTROL FREEHAND SYSTEM(R)
FDA PMA · Stimulator, neuromuscular, implanted · Biocontrol Technology, Inc.
Key facts
| PMA number | P950035 |
|---|---|
| Trade name | NEUROCONTROL FREEHAND SYSTEM(R) |
| Generic name | Stimulator, neuromuscular, implanted |
| Applicant | Biocontrol Technology, Inc. |
| Product code | GZC |
| Approval date | Aug 15, 1997 |
| Docket number | 97M-0458 |
| Notice date | Nov 14, 1997 |
At a glance
- 10–99 Supplements
- Jan 18, 2002 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: