PMA P010030S157

Device
LifeVest® Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S157
Product code
MVK
Decision date
2022-01-25
Generic name
Wearable automated external defibrillator
Approval order statement
Update to the Automated Belt Test System, Version 2.2.

Current openFDA PMA Record#

Device
LifeVest® Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S157
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2022-01-25
Decision code
OK30
Date received
2022-01-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the Automated Belt Test System, Version 2.2.