PMA P160015S002

Device
CPR Stat-Padz Electrode and CPR-D Padz Electrode
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S002
Product code
MKJ
Decision date
2019-03-27
Classification
Automated External Defibrillators (non-wearable)
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for automation of a soldering process.

Current openFDA PMA Record#

Device
CPR Stat-Padz Electrode and CPR-D Padz Electrode
Applicant
ZOLL Medical Corporation
PMA number
P160015
Supplement
S002
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2019-03-27
Decision code
APPR
Date received
2018-08-23
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for automation of a soldering process.