PMA P160033S011

Device: Powerheart® G5
Applicant: ZOLL Medical Corporation
PMA number: P160033
Supplement: S011
Product code: MKJ
Decision date: 2026-04-28
Classification: Cardiovascular
Generic name: Automated external defibrillators (non-wearable)
Approval order statement: approval for update to the software resulting in version v4.31. This version includes cybersecurity enhancements, removal of configurability of the rescue protocol, and disabling of the manufacturing/debug serial port.

Current openFDA PMA Record#

Device: Powerheart® G5
Applicant: ZOLL Medical Corporation
PMA number: P160033
Supplement: S011
Product code: MKJ
Generic name: Automated external defibrillators (non-wearable)
Decision date: 2026-04-28
Decision code: APPR
Date received: 2026-01-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for update to the software resulting in version v4.31. This version includes cybersecurity enhancements, removal of configurability of the rescue protocol, and disabling of the manufacturing/debug serial port.