PMA supplement
P860026 S004: DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
FDA PMA supplement · Normal 180 Day Track · Avery Biomedical Devices, Inc.
Key facts
| Original PMA | P860026 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR |
| Generic name | Implanted diaphragmatic/phrenic nerve Stimulator |
| Applicant | Avery Biomedical Devices, Inc. |
| Product code | GZE |
| Received date | Aug 10, 1993 |
| Decision date | Mar 3, 1998 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: