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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 NumberS009
Date Received12/17/2021
Decision Date03/10/2022
Product Code MWG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new material plasticizer for the tubing associated with the TherOx SSO2 DownStream Cartridge, part of the TherOx Downstream System.
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