PMA supplement
P200007 S001: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
FDA PMA supplement · 135 Review Track For 30-Day Notice · Graphic Controls D.B.A. Vermed
Key facts
| Original PMA | P200007 |
|---|---|
| Supplement number | S001 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Graphic Controls D.B.A. Vermed |
| Product code | MKJ |
| Received date | Apr 18, 2025 |
| Decision date | Nov 12, 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: