PMA P230022S006
- 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
- S006
- Product code
- MVK
- Decision date
- 2026-01-13
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- the use of an alternate supplier for a coating process
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
- S006
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2026-01-13
- Decision code
- OK30
- Date received
- 2025-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of an alternate supplier for a coating process