PMA P230022S002

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
Applicant: Element Science, Inc.
PMA number: P230022
Supplement: S002
Product code: MVK
Decision date: 2025-11-18
Classification: Cardiovascular
Generic name: Wearable automated external defibrillator
Approval order statement: approval for minor design changes to the PCBA assembly enclosure and alternative materials used in the PCB

Current openFDA PMA Record#

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
Applicant: Element Science, Inc.
PMA number: P230022
Supplement: S002
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2025-11-18
Decision code: APPR
Date received: 2025-08-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for minor design changes to the PCBA assembly enclosure and alternative materials used in the PCB