PMA supplement
P010030 S086: WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.
FDA PMA supplement · Normal 180 Day Track No User Fee · Zoll Manufacturing Corporation
Key facts
| Original PMA | P010030 |
|---|---|
| Supplement number | S086 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000. |
| Generic name | Wearable automated external defibrillator |
| Applicant | Zoll Manufacturing Corporation |
| Product code | MVK |
| Received date | Oct 27, 2016 |
| Decision date | Apr 25, 2017 |
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: