Assure Wearable Cardioverter Defibrillator (WCD) system
FDA premarket approval P200037/S004 · decided 2022-10-25
Approval details
- PMA number
- P200037
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- 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
- 2022-06-02
- Decision date
- 2022-10-25
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kirkland, WA
- Statement
- Approval for a revision to the software system to version 5.0 with a feature to provide additional information to the physician about the patients health.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |