PMA P230022S001

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: S001
Product code: MVK
Decision date: 2025-08-20
Classification: Cardiovascular
Generic name: Wearable automated external defibrillator
Approval order statement: approval of the 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: S001
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2025-08-20
Decision code: APPR
Date received: 2025-05-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the 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