PMA
P200004: ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
FDA PMA · Automated external defibrillators (non-wearable) · Conmed Corporation
Key facts
| PMA number | P200004 |
|---|---|
| Trade name | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Conmed Corporation |
| Owner/operator | CONMED CORPORATION |
| Product code | MKJ |
| Approval date | Sep 26, 2021 |
| Docket number | 21M-1046 |
| Notice date | Sep 28, 2021 |
| Establishment registration | 1320894 |
| FEI number | 3001451571 |
At a glance
- 1–9 Supplements
- Jun 16, 2022 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- No Withdrawn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: