PMA P160026S020

Device
LIFEPAK Automated External Defibrillators
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S020
Product code
MKJ
Decision date
2020-09-16
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval of the removal of a redundant capacitor C181 that causes physical interference between the C181 capacitor and front case assembly.

Current openFDA PMA Record#

Device
LIFEPAK Automated External Defibrillators
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S020
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-09-16
Decision code
APPR
Date received
2020-06-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of the removal of a redundant capacitor C181 that causes physical interference between the C181 capacitor and front case assembly.