Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
FDA premarket approval P230022 · decided 2025-04-30
Approval details
- PMA number
- P230022
- Trade name
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
- Generic name
- Wearable automated external defibrillator
- Applicant
- Element Science, Inc.
- Date received
- 2023-07-03
- Decision date
- 2025-04-30
- Days to decision
- 667 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood City, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.