ASSURE Wearable Cardioverter Defibrillator (WCD) System
FDA premarket approval P200037/S017 · decided 2025-07-22
Approval details
- PMA number
- P200037
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ASSURE Wearable Cardioverter Defibrillator (WCD) System
- Generic name
- Wearable automated external defibrillator
- Applicant
- Kestra Medical Technologies, Inc.
- Date received
- 2025-06-26
- Decision date
- 2025-07-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kirkland, WA
- Statement
- approval of a new process for rework of therapy cables
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |