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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 NumberS001
Date Received04/29/2019
Decision Date11/20/2020
Product Code MWG 
Advisory Committee Cardiovascular
Clinical TrialsNCT02603835
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Therox Downstream System. The device is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
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