PMA P160026S070

Device: LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S070
Product code: MKJ
Decision date: 2026-07-30
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: implementation of an in-process verification method during assembly

Current openFDA PMA Record#

Device: LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Applicant: Physio-Control, Inc.
PMA number: P160026
Supplement: S070
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-07-30
Decision code: OK30
Date received: 2026-07-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an in-process verification method during assembly