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PMA P170027S001

Device
TherOx DownStream System
Applicant
Zoll Circulation, Inc.
Product code
MWG
Decision date
2020-11-20
Generic name
System, oxygen, aqueous
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.

Current openFDA PMA Record#

Device
TherOx DownStream System
Applicant
Zoll Circulation, Inc.
PMA number
P170027
Supplement
S001
Product code
MWG
Generic name
System, oxygen, aqueous
Decision date
2020-11-20
Decision code
APPR
Date received
2019-04-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
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.