PMA
P210015: Avive Automated External Defibrillator (AED) System
FDA PMA · Automated external defibrillators (non-wearable) · Avive Solutions, Inc.
Key facts
| PMA number | P210015 |
|---|---|
| Trade name | Avive Automated External Defibrillator (AED) System |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Avive Solutions, Inc. |
| Owner/operator | Avive Solutions Inc |
| Product code | MKJ |
| Approval date | Oct 31, 2022 |
| Docket number | 22M-2741 |
| Notice date | Nov 4, 2022 |
| Establishment registration | 3026007685 |
| FEI number | 3026007685 |
At a glance
- 1–9 Supplements
- Aug 13, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: