| 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. |
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| Device | TherOx Downstream System |
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| Generic Name | System, oxygen, aqueous |
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| Applicant | ZOLL Circulation, Inc.
2000 Ringwood Ave
San Jose, CA 95131 |
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| PMA Number | P170027 |
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| Date Received | 09/15/2017 |
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| Decision Date | 04/02/2019 |
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| Product Code |
MWG |
| Docket Number | 19M-1582 |
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| Notice Date | 04/04/2019 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT02603835
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S002 S001 S004 S005 S008 S010 S006 S003 S009 S007 S013
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