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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 System
Generic NameSystem, oxygen, aqueous
ApplicantZoll Circulation, Inc.
2000 Ringwood Ave.
San Jose, CA 95131
PMA NumberP170027
Supplement NumberS005
Date Received03/23/2021
Decision Date06/01/2021
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 (2000 Ringwood Ave, San Jose, CA, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the TherOx® DownStream® System Console only.
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