PMA
P810033: SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355
FDA PMA · Electrode, stabilized epidural spinal · Avery Biomedical Devices, Inc.
Key facts
| PMA number | P810033 |
|---|---|
| Trade name | SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355 |
| Generic name | Electrode, stabilized epidural spinal |
| Applicant | Avery Biomedical Devices, Inc. |
| Owner/operator | AVERY BIOMEDICAL DEVICES, INC. |
| Product code | LHY |
| Approval date | Feb 2, 1982 |
| Docket number | 82M-0036 |
| Notice date | Mar 2, 1982 |
| Establishment registration | 2427696 |
| FEI number | 2427696 |
At a glance
- None Supplements
- Feb 2, 1982 Latest supplement decision
- Yes Withdrawn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: