Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
FDA premarket approval P230022/S002 · decided 2025-11-18
Approval details
- PMA number
- P230022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
- Generic name
- Wearable automated external defibrillator
- Applicant
- Element Science, Inc.
- Date received
- 2025-08-28
- Decision date
- 2025-11-18
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- approval for minor design changes to the PCBA assembly enclosure and alternative materials used in the PCB
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