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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.
 
DeviceAED 3 Defibrillator with Uni-Padz
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
Chelmsford, MA 01824
PMA NumberP160015
Supplement NumberS004
Date Received03/27/2020
Decision Date06/05/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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