LIFEPAK CR2 Defibrillator

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P170018 S003

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 use of an alternate high-voltage capacitor from an alternate supplier.

DeviceLIFEPAK CR2 Defibrillator
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control, Inc
Date Received2019-01-15
Decision Date2019-05-02
PMAP170018
SupplementS003
Product CodeMKJ
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
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
P170018Original Filing
S015 2022-10-13 Real-time Process
S014 2022-07-27 Real-time Process
S013 2021-05-17 30-day Notice
S012 2021-01-25 Special (immediate Track)
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

Device IDPMASupp
00883873867808 P170018 000
00883873871577 P170018 000
00883873790687 P170018 000
00883873824061 P170018 002
00883873824078 P170018 002
00883873824085 P170018 002
00883873824092 P170018 002
00883873824108 P170018 002
00883873824115 P170018 002
00883873824122 P170018 002
00883873824139 P170018 002

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