PMA P170018S024

Device
LIFEPACK® CR2 Automated External Defibrillator (AED)
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S024
Product code
MKJ
Decision date
2025-09-29
Classification
Cardiovascular
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
implementation of an additional assembly workstation

Current openFDA PMA Record#

Device
LIFEPACK® CR2 Automated External Defibrillator (AED)
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S024
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2025-09-29
Decision code
OK30
Date received
2025-09-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
implementation of an additional assembly workstation