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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTherOx Downstream System
Generic Namesystem, oxygen, aqueous
Applicant
TherOx, Inc.
17500 cartwright rd
suite 100
irvine, CA 92614-5846
PMA NumberP170027
Date Received09/15/2017
Decision Date04/02/2019
Product Code MWG 
Docket Number 19M-1582
Notice Date 04/04/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02603835
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the TherOx Downstream System. This device is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patients 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 
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