PMA supplement
P190013 S001: DBP-1400-ABE and DBP-2003- ABE
FDA PMA supplement · Normal 180 Day Track · Aed Battery Exchange, LLC
Key facts
| Original PMA | P190013 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DBP-1400-ABE and DBP-2003- ABE |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Aed Battery Exchange, LLC |
| Product code | MKJ |
| Received date | Apr 3, 2025 |
| Decision date | Oct 28, 2025 |
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: