PMA supplement
P160022 S025: X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™
FDA PMA supplement · 30-Day Notice · ZOLL Medical Corporation
Key facts
| Original PMA | P160022 |
|---|---|
| Supplement number | S025 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | ZOLL Medical Corporation |
| Product code | MKJ |
| Received date | Dec 21, 2020 |
| Decision date | Jan 5, 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: