PMA P230022S004

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Applicant: Element Science, Inc.
PMA number: P230022
Supplement: S004
Product code: MVK
Decision date: 2025-11-19
Classification: Cardiovascular
Generic name: Wearable automated external defibrillator
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230022.

Current openFDA PMA Record#

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Applicant: Element Science, Inc.
PMA number: P230022
Supplement: S004
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2025-11-19
Decision code: APPR
Date received: 2025-10-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230022.