LIFEPAK® CR2 Defibrillator

FDA Premarket Approval P170018 S015

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

DeviceLIFEPAK® CR2 Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-10-13
Decision Date2023-01-10
PMAP170018
SupplementS015
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressPhysio-Control, Inc
11811 Willows Road Ne
redmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Adding A Clip Over The Magnetic Component In The LIFEPAK CR2 Defibrillator Lid.

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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