PMA
P860026: DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
FDA PMA · Implanted diaphragmatic/phrenic nerve Stimulator · Avery Biomedical Devices, Inc.
Key facts
| PMA number | P860026 |
|---|---|
| Trade name | DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR |
| Generic name | Implanted diaphragmatic/phrenic nerve Stimulator |
| Applicant | Avery Biomedical Devices, Inc. |
| Owner/operator | AVERY BIOMEDICAL DEVICES, INC. |
| Product code | GZE |
| Approval date | Jan 5, 1987 |
| Docket number | 87M-0022 |
| Notice date | Feb 25, 1987 |
| Establishment registration | 2427696 |
| FEI number | 2427696 |
At a glance
- 10–99 Supplements
- Nov 4, 2019 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: