PMA
P200037: ASSURE Wearable Cardioverter Defibrillator (WCD) System
FDA PMA · Wearable automated external defibrillator · Kestra Medical Technologies, Inc.
Key facts
| PMA number | P200037 |
|---|---|
| Trade name | ASSURE Wearable Cardioverter Defibrillator (WCD) System |
| Generic name | Wearable automated external defibrillator |
| Applicant | Kestra Medical Technologies, Inc. |
| Owner/operator | Kestra Medical |
| Product code | MVK |
| Approval date | Jul 27, 2021 |
| Docket number | 21M-0820 |
| Notice date | Jul 29, 2021 |
| Establishment registration | 3015185344 |
| FEI number | 3015185344 |
At a glance
- 10–99 Supplements
- Sep 28, 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- No Withdrawn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: