LIFEPAK CR2 Automated External Defibrillator

FDA Premarket Approval P170018 S010

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 to replace machine vision equipment used in manufacturing the lifepak cr2 automated external defibrillator

DeviceLIFEPAK CR2 Automated External Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control, Inc
Date Received2020-09-11
Decision Date2020-10-04
PMAP170018
SupplementS010
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Physio-Control, Inc 11811 Willows Road Ne redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P170018Original Filing
S011 2020-10-02 30-day Notice
S010 2020-09-11 30-day Notice
S009 2020-09-10 30-day Notice
S008 2020-08-26 30-day Notice
S007 2020-06-12 Real-time Process
S006 2020-04-23 30-day Notice
S005
S004 2019-09-11 Real-time Process
S003 2019-01-15 Real-time Process
S002 2019-01-11 Real-time Process
S001 2018-12-31 30-day Notice

NIH GUDID Devices

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