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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceHOSPITAL WEARABLE DEFIBRILLATOR (HWD 1000)
Generic NameWearable automated external defibrillator
ApplicantZOLL MANUFACTURING CORPORATION
121 GAMMA DR
PITTSBURGH, PA 15238-0000
PMA NumberP010030
Supplement NumberS067
Date Received10/02/2015
Decision Date02/24/2017
Product Code MVK 
Advisory Committee Cardiovascular
Clinical TrialsNCT02122549
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the HWD 1000 System. This is a wearable defibrillation for hospital use that is based on the previously approved LifeVest Wearable Cardioverter Defibrillator (WCD) 4000 design as a platform and incorporates design features from the previously approved WCD 3000S.
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