PMA P160012S006

Device: QUIK-PAK Electrodes
Applicant: Physio-Control, Inc.
PMA number: P160012
Supplement: S006
Product code: MKJ
Decision date: 2022-07-20
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for a temporary shelf-life extension up to 9 months beyond the expiration date for units already distributed in the field that meet the required storage conditions.

Current openFDA PMA Record#

Device: QUIK-PAK Electrodes
Applicant: Physio-Control, Inc.
PMA number: P160012
Supplement: S006
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2022-07-20
Decision code: APPR
Date received: 2022-05-16
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a temporary shelf-life extension up to 9 months beyond the expiration date for units already distributed in the field that meet the required storage conditions.