Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceLIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantPhysio-Control, Inc.
11811 Willows Rd. NE
Redmond, WA 98052
PMA NumberP160026
Date Received07/25/2016
Decision Date07/02/2018
Product Code MKJ 
Docket Number 18M-2883
Notice Date 08/22/2018
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-ion Rechargeable Battery, LIFEPAK® 20 Defibrillator/ Monitor (Refurbished), LIFEPAK® 20e Defibrillator/ Monitor, LIFEPAK® 15 Monitor/Defibrillator, and LIFEPAK® Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Monitor/Defibrillator) These devices are indicated for use as follows:LIFEPAK® 1000 DefibrillatorThe defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. The defibrillator may be used with standard defibrillation pads only on adults and children who are 8 years old or more or who weigh more than 25 kg (55 lbs). The defibrillator may be used on children who are less than 8 years old or weigh less than 25 kg (55 lbs) with Infant/Child Reduced Energy Defibrillation Electrodes.LIFEPAK® 20/20e Defibrillator/Monitors The AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. In AED mode, the LIFEPAK® 20 and LIFEPAK® 20e defibrillator/monitor is not intended for use on pediatric patients less than 8 years old. LIFEPAK® 15 Defibrillator/Monitors AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patients ECG rhythm. In AED mode, the LIFEPAK® 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S013  S001 S010 S016 S017 S018 S030 S031 S032 S028 S029 
S025 S034 S035 S042 S043 S044 S045 S047 S048 S049 S057 S051 
S052 S046 S002 S006 S007 S011 S012 S040 S041 S066 S067 S059 
S060 S061 S053 S054 S055 S056 S068 S070 S019 S020 S014 S003 
S015 S008 S009 S004 S005 S026 S027 S063 S064 S065 S023 S024 
S036 S037 S033 S038 S039 S050 S062 
-
-