LIFEPAK® CR2 Defibrillator

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P170018

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the lifepak® cr2 defibrillator. The device is indicated for use on patients 1 year of age and older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprcoach feedback technology in the lifepak® cr2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides cpr guidance in accordance with the aha guidelines for patients 1 year of age and older. The lifepak® cr2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/aed, advanced life support or a physician-authorized emergency medical response training program. The lifepak® cr2 defibrillator is indicated to be used with the quik-step pacing/ecg defibrillation electrodes and the lifepak cr2 lithium battery.

• Device: LIFEPAK® CR2 Defibrillator
• Classification Name: Automated External Defibrillators (non-wearable)
• Generic Name: Automated External Defibrillators (non-wearable)
• Applicant: Physio-Control, Inc
• Date Received: 2017-05-31
• Decision Date: 2018-12-21
• Notice Date: 2019-02-12
• PMA: P170018
• Supplement: S
• Product Code: MKJ
• Docket Number: 19M-4916
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Physio-Control, Inc 11811 Willows Road Ne redmond, WA 98052
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P170018		Original 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 ID	PMA	Supp
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