PMA supplement
P160012 S003: Infant/Child Reduced Energy Defibrillation Electrodes
FDA PMA supplement · Normal 180 Day Track · Physio-Control, Inc.
Key facts
| Original PMA | P160012 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Infant/Child Reduced Energy Defibrillation Electrodes |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Physio-Control, Inc. |
| Product code | MKJ |
| Received date | Jan 30, 2020 |
| Decision date | Jul 8, 2021 |
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: