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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
Generic NameSystem, oxygen, aqueous
ApplicantZoll Circulation, Inc.
2000 Ringwood Ave.
San Jose, CA 95131
PMA NumberP170027
Supplement NumberS019
Date Received05/21/2025
Decision Date06/20/2025
Product Code MWG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to change the manufacturing location for the capillary component of the TherOx DownStream Cartridge
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