PMA P160026S025

Device
LIFEPAK® 1000 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S025
Product code
MKJ
Decision date
2021-04-27
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Replacement of the washing system used during capacitor manufacturing for the LifePack 1000 Defibrillator.

Current openFDA PMA Record#

Device
LIFEPAK® 1000 Defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S025
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2021-04-27
Decision code
OK30
Date received
2021-03-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the washing system used during capacitor manufacturing for the LifePack 1000 Defibrillator.