LIFEPAK CR2 Defibrillator

FDA Premarket Approval P170018 S007

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

A change in printed circuit board laminate material and material supplier

DeviceLIFEPAK CR2 Defibrillator
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantPhysio-Control, Inc
Date Received2020-06-12
Decision Date2020-08-27
PMAP170018
SupplementS007
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
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
00883873790687 P170018 000
00883873790687 P170018 000
00883873790687 P170018 000
00883873824078 P170018 002
00883873824061 P170018 002
00883873824139 P170018 002
00883873824122 P170018 002
00883873824115 P170018 002
00883873824108 P170018 002
00883873824092 P170018 002
00883873824085 P170018 002
00883873824078 P170018 002
00883873824061 P170018 002
00883873824085 P170018 002
00883873824092 P170018 002
00883873824122 P170018 002
00883873824115 P170018 002
00883873824108 P170018 002
00883873824092 P170018 002
00883873824085 P170018 002
00883873824078 P170018 002
00883873824061 P170018 002
00883873824139 P170018 002
00883873824122 P170018 002
00883873824115 P170018 002
00883873824108 P170018 002
00883873824139 P170018 002

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