PMA
P010030: WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
FDA PMA · Wearable automated external defibrillator · Zoll Manufacturing Corporation
Key facts
| PMA number | P010030 |
|---|---|
| Trade name | WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST |
| Generic name | Wearable automated external defibrillator |
| Applicant | Zoll Manufacturing Corporation |
| Owner/operator | ZOLL Manufacturing Corporation |
| Product code | MVK |
| Approval date | Dec 18, 2001 |
| Docket number | 02M-0145 |
| Notice date | Apr 12, 2002 |
| Establishment registration | 3008642652 |
| FEI number | 3008642652 |
At a glance
- 100–999 Supplements
- Oct 6, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: