PMA supplement
P160022 S050: CPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep
FDA PMA supplement · Real-Time Process · ZOLL Medical Corporation
Key facts
| Original PMA | P160022 |
|---|---|
| Supplement number | S050 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CPR Uni-padz, CPR-D-padz, OneStep Basic, OneStep CPR, OneStep CPR A/A, OneStep Pediatric, OneStep Pediatric CPR, OneStep |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | ZOLL Medical Corporation |
| Product code | MKJ |
| Received date | Jan 30, 2026 |
| Decision date | Apr 28, 2026 |
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: