PMA P010030S182
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S182
- Product code
- MVK
- Decision date
- 2024-09-18
- Classification
- Cardiovascular
- Generic name
- Wearable automated external defibrillator
- Approval order statement
- approval for adding a connector to attach the speaker to the printed circuit assembly (PCA).
Current openFDA PMA Record#
- Device
- LifeVest® Wearable Defibrillator
- Applicant
- Zoll Manufacturing Corporation
- PMA number
- P010030
- Supplement
- S182
- Product code
- MVK
- Generic name
- Wearable automated external defibrillator
- Decision date
- 2024-09-18
- Decision code
- APPR
- Date received
- 2024-06-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for adding a connector to attach the speaker to the printed circuit assembly (PCA).