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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.
 
DeviceWEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 3000, 3100, 4000.
Generic Namewearable automated external defibrillator
Applicant
ZOLL MANUFACTURING CORPORATION
121 gamma dr
pittsburgh, PA 15238-0000
PMA NumberP010030
Supplement NumberS086
Date Received10/27/2016
Decision Date04/25/2017
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the Zoll Wearable Cardioverter Defibrillator (WCD) 3000, 3100, and 4000 Operators Manuals to reflect the results of the Post-Approval Study.
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