FDA.reportPublic FDA data

PMA P010030S116

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S116
Product code
MVK
Decision date
2019-03-27
Classification
Wearable Automated External Defibrillator
Generic name
Wearable automated external defibrillator
Approval order statement
New solder paste printer, solder paste inspection system, and glue dispenser equipment on the Surface Mount Line used during the PCA manufacturing process.

Current openFDA PMA Record#

Device
LifeVest Wearable Defibrillator
Applicant
Zoll Manufacturing Corporation
PMA number
P010030
Supplement
S116
Product code
MVK
Generic name
Wearable automated external defibrillator
Decision date
2019-03-27
Decision code
OK30
Date received
2019-03-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New solder paste printer, solder paste inspection system, and glue dispenser equipment on the Surface Mount Line used during the PCA manufacturing process.