| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati |
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| Generic Name | Wearable automated external defibrillator |
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| Applicant | Element Science, Inc.
301 Chesapeake Dr.
Redwood City, CA 94063 |
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| PMA Number | P230022 |
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| Date Received | 07/03/2023 |
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| Decision Date | 04/30/2025 |
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| Product Code |
MVK |
| Docket Number | FDA-7380 |
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| Notice Date | 12/29/2025 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT05201495
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) ("Jewel"), Jewel P-WCD Firmware, Device Accessories Skin Preparation Kit, Placement Accessory, Device Removal Kit, Optional Software Accessories ES Mobile Application, ES Cloud, ES Report Generator, ES Clinical Portal. The Jewel P-WCD is indicated for adult patients 18 years of age and older who are at risk for Sudden Cardiac Arrest, and either are not candidates for or refuse an Implantable Defibrillator. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S004 S006 |
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