PMA supplement
P210015 S002: Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter
FDA PMA supplement · Normal 180 Day Track No User Fee · Avive Solutions, Inc.
Key facts
| Original PMA | P210015 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Avive AED, Avive AED Pad Cartridge, Avive AED Training Cartridge, Avive USB Charging Cable, Avive USB Power Adapter |
| Generic name | Automated external defibrillators (non-wearable) |
| Applicant | Avive Solutions, Inc. |
| Product code | MKJ |
| Received date | Feb 16, 2024 |
| Decision date | Aug 15, 2024 |
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: