LIFEPAK 20e defibrillator/monitor

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160026 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a new microcontroller component, which is located on the power pcba, and associated supporting subcomponents on the pcba.

DeviceLIFEPAK 20e defibrillator/monitor
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control. Inc.
Date Received2019-08-29
Decision Date2019-11-25
PMAP160026
SupplementS011
Product CodeMKJ
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Physio-Control. Inc. 11811 Willows Road Ne redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P160026Original Filing
S011 2019-08-29 Normal 180 Day Track
S010 2019-06-07 Normal 180 Day Track
S009 2019-04-24 Real-time Process
S008 2019-04-22 30-day Notice
S007
S006 2019-04-11 30-day Notice
S005 2018-12-28 30-day Notice
S004 2018-12-26 Real-time Process
S003 2018-11-09 30-day Notice
S002 2018-10-01 30-day Notice
S001 2018-07-19 Real-time Process

NIH GUDID Devices

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