ASSURE Wearable Cardioverter Defibrillator (WCD) System
FDA premarket approval P200037 · decided 2021-07-27
Approval details
- PMA number
- P200037
- Trade name
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Generic name
- Wearable automated external defibrillator
- Applicant
- Kestra Medical Technologies, Inc.
- Date received
- 2020-08-13
- Decision date
- 2021-07-27
- Days to decision
- 348 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kirkland, WA
- Statement
- Approval for the ASSURE system which is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |