PMA supplement
P010030 S056: LIFEVEST WEARABLE DEFIBRILLATOR
FDA PMA supplement · Panel Track · Zoll Manufacturing Corporation
Key facts
| Original PMA | P010030 |
|---|---|
| Supplement number | S056 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LIFEVEST WEARABLE DEFIBRILLATOR |
| Generic name | Wearable automated external defibrillator |
| Applicant | Zoll Manufacturing Corporation |
| Product code | MVK |
| Received date | Feb 19, 2013 |
| Decision date | Dec 17, 2015 |
| Docket number | 15M-3521 |
| Notice date | Dec 24, 2015 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: