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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.
 
DeviceTherOx® DownStream® Cartridge (DSC-2)
Generic NameSystem, oxygen, aqueous
ApplicantZoll Circulation, Inc.
2000 Ringwood Ave.
San Jose, CA 95131
PMA NumberP170027
Supplement NumberS012
Date Received11/03/2023
Decision Date06/06/2024
Product Code MWG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at ZOLL Circulation Facility (ERN/FEI: 301061700, 2000 Ringwood Ave, San Jose, CA, 95131) for the manufacturing of the TherOx DownStream® Cartridge
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