PMA
P190007: Cardinal Health Multifunctional Defibrillation Electrode
FDA PMA · Automated external defibrillators (non-wearable) · Cardinalhealth
Key facts
| PMA number | P190007 |
|---|---|
| Trade name | Cardinal Health Multifunctional Defibrillation Electrode |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Cardinalhealth |
| Owner/operator | Cardinal Health 200, LLC |
| Product code | MKJ |
| Approval date | Aug 7, 2020 |
| Docket number | 20M-1752 |
| Notice date | Aug 12, 2020 |
| Establishment registration | 2183164 |
| FEI number | 1000116809 |
At a glance
- None Supplements
- Aug 7, 2020 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: