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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameWEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 "LIFEVEST"
Classification Namewearable automated external defibrillator
ApplicantZOLL LIFECOR CORPORATION
PMA NumberP010030
Date Received05/04/2001
Decision Date12/18/2001
Product Code
MVK[ Registered Establishments with MVK ]
Docket Number 02M-0145
Notice Date 04/12/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the wcd 2000 system. This device is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 
S037 S038 S039 S041 
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