PMA P010030S140

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S140
Product code
MVK
Decision date
2020-07-02
Generic name
Wearable automated external defibrillator
Approval order statement
Manufacturing fixture to discharge batteries to the optimal storage voltage.

Current openFDA PMA Record#

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S140
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2020-07-02
Decision code
OK30
Date received
2020-06-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing fixture to discharge batteries to the optimal storage voltage.