PMA P010030S139

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S139
Product code
MVK
Decision date
2020-06-17
Generic name
Wearable automated external defibrillator
Approval order statement
Solder paste inspection system for the battery printed circuit assembly.

Current openFDA PMA Record#

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S139
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2020-06-17
Decision code
OK30
Date received
2020-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Solder paste inspection system for the battery printed circuit assembly.