PMA P010030S125

Device: LifeVest Wearable Defibrillator
Applicant: Zoll Manufacturing Corporation
PMA number: P010030
Supplement: S125
Product code: MVK
Decision date: 2019-09-03
Classification: Wearable Automated External Defibrillator
Generic name: Wearable automated external defibrillator
Approval order statement: Replace the cleaning solvent used during the manufacture of the therapy electrodes and addition of distilled water to the cleaning process.

Current openFDA PMA Record#

Device: LifeVest Wearable Defibrillator
Applicant: Zoll Manufacturing Corporation
PMA number: P010030
Supplement: S125
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2019-09-03
Decision code: OK30
Date received: 2019-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace the cleaning solvent used during the manufacture of the therapy electrodes and addition of distilled water to the cleaning process.