PMA P010030S126

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S126
Product code
MVK
Decision date
2019-10-21
Classification
Wearable Automated External Defibrillator
Generic name
Wearable automated external defibrillator
Approval order statement
Implement a fixture to screen the fastener used in the LifeVest 4000 Electrode Belt.

Current openFDA PMA Record#

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S126
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2019-10-21
Decision code
OK30
Date received
2019-09-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement a fixture to screen the fastener used in the LifeVest 4000 Electrode Belt.