PMA P170018S014

Device: LIFEPAK® CR2 Defibrillator
Applicant: Physio-Control, Inc.
PMA number: P170018
Supplement: S014
Product code: MKJ
Decision date: 2022-09-27
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: Approval for a new packaging design, which will include new corrugated cardboard packaging components to replace the current packaging components.

Current openFDA PMA Record#

Device: LIFEPAK® CR2 Defibrillator
Applicant: Physio-Control, Inc.
PMA number: P170018
Supplement: S014
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2022-09-27
Decision code: APPR
Date received: 2022-07-27
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new packaging design, which will include new corrugated cardboard packaging components to replace the current packaging components.