PMA P160026S007

Device
LIFEPAK 1000 defibrillator
Applicant
Physio-Control, Inc.
Product code
MKJ
Decision date
2019-07-16
Generic name
Automated external defibrillators (non-wearable)
Approval order statement
Approval for a material change for the J507 connector on the Angelina PCBA for the LIFEPAK 1000 defibrillator.

Current openFDA PMA Record#

Device
LIFEPAK 1000 defibrillator
Applicant
Physio-Control, Inc.
PMA number
P160026
Supplement
S007
Product code
MKJ
Generic name
Automated external defibrillators (non-wearable)
Decision date
2019-07-16
Decision code
APPR
Date received
2019-04-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a material change for the J507 connector on the Angelina PCBA for the LIFEPAK 1000 defibrillator.