PMA P160026S073

Device
LIFEPAK® 15 monitor/defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S073
Product code
MKJ
Decision date
2026-09-10
Classification
Cardiovascular
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
removal of an incoming inspection process step

Current openFDA PMA Record#

Device
LIFEPAK® 15 monitor/defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S073
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2026-09-10
Decision code
OK30
Date received
2026-08-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
removal of an incoming inspection process step