FDA.reportPublic FDA data

PMA P170018S009

Device
LIFEPAK CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S009
Product code
MKJ
Decision date
2020-10-07
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Changes to the Initial Software Load (ISL) and Final Configuration (FC) manufacturing test system software used in the manufacture of the LIFEPAK CR2 Automated External Defibrillator.

Current openFDA PMA Record#

Device
LIFEPAK CR2 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P170018
Supplement
S009
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2020-10-07
Decision code
OK30
Date received
2020-09-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the Initial Software Load (ISL) and Final Configuration (FC) manufacturing test system software used in the manufacture of the LIFEPAK CR2 Automated External Defibrillator.