ASSURE Wearable Cardioverter Defibrillator (WCD) System
FDA premarket approval P200037/S001 · decided 2021-11-19
Approval details
- PMA number
- P200037
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Generic name
- Wearable automated external defibrillator
- Applicant
- Kestra Medical Technologies, Inc.
- Date received
- 2021-09-15
- Decision date
- 2021-11-19
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kirkland, WA
- Statement
- Approval for a software update in the off-the-shelf software and resolution of unresolved anomalies.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |