PMA
P200007: HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
FDA PMA · Automated external defibrillators (non-wearable) · Graphic Controls D.B.A. Vermed
Key facts
| PMA number | P200007 |
|---|---|
| Trade name | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Graphic Controls D.B.A. Vermed |
| Owner/operator | Nissha Medical Technologies |
| Product code | MKJ |
| Approval date | Jun 23, 2023 |
| Docket number | 23M-3187 |
| Notice date | Aug 4, 2023 |
| Establishment registration | 1317188 |
| FEI number | 1317188 |
At a glance
- 1–9 Supplements
- Dec 19, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: