PMA P170018S023

Device
LIFEPAK® CR2 Automated External Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S023
Product code
MKJ
Decision date
2025-11-06
Classification
Cardiovascular
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
approval for minor design changes to the LIFEPAK CR2 (LPCR2) QUIK-STEP™ Pacing/ECG/Defibrillation electrodes.

Current openFDA PMA Record#

Device
LIFEPAK® CR2 Automated External Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S023
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2025-11-06
Decision code
APPR
Date received
2025-08-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for minor design changes to the LIFEPAK CR2 (LPCR2) QUIK-STEP™ Pacing/ECG/Defibrillation electrodes.