PMA P010030S142

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S142
Product code
MVK
Decision date
2020-09-17
Generic name
Wearable automated external defibrillator
Approval order statement
Update to the Automated Test System for the LifeVest 4000 electrode belts.

Current openFDA PMA Record#

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S142
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2020-09-17
Decision code
OK30
Date received
2020-09-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the Automated Test System for the LifeVest 4000 electrode belts.